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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 5  |  Issue : 3  |  Page : 117-124

Clinical evaluation of the effect of Saptasaram Kashaya and Saraswatarishta in Kashtartava (primary dysmenorrhea)


1 Regional Ayurveda Research Institute (RARI), Thiruvananthapuram, Kerala, India
2 Central Ayurveda Research Institute (CARI), New Delhi, India
3 Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, India
4 National Ayurveda Research Institute for Panchakarma, Cheruthuruthi, Kerala, India

Date of Submission12-Oct-2021
Date of Acceptance01-Feb-2022
Date of Web Publication22-Mar-2022

Correspondence Address:
Emy S Surendran
Regional Ayurveda Research Institute (RARI), Thiruvananthapuram, Kerala.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_87_21

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  Abstract 

BACKGROUND: Primary dysmenorrhea is defined as painful menstruation without any associated pelvic pathology. This debilitating gynecologic disease affects 45–90% of women of reproductive age. In classical texts of Ayurveda, formulations such as Saptasaram Kashaya (SPK) and Saraswatarishta (SSR) have been indicated in the treatment of Kashtartava (primary dysmenorrhea). Based on the classical claim, the present work was planned to assess the effect of SPK and SSR on the treatment of primary dysmenorrhea. MATERIALS AND METHODS: Unmarried girls of age between 13 and 20 years, suffering from at least three painful cycles of menstruation in the last 6 months with pain intensity more than 40 mm as per the Visual Analog Scale (700 mm) (VAS), were included in the trial. Ayurvedic formulations SPK in the dose of 50 ml twice daily before food from the onset of menstruation till next 7 days and SSR in the dose of 10 ml mixed with 20 ml of lukewarm water at bedtime daily were administered for 3 consecutive months. The effect on menstrual pain was assessed by VAS; improvement in quality of life was assessed using the SF-36 (RAND) questionnaire; and changes in the psychosomatic status were assessed using the Menstrual Distress Questionnaire and Hamilton Anxiety Scale. RESULTS: A total of 100 participants were enrolled at two study centers. The data of 96 participants who completed 6 months’ trial period were analyzed. At baseline, the mean VAS score for pain was 90.9 ± 12.3, which decreased to 33.4 ± 24 on the 90th day and further reduced to 23.8 ± 21.3 on the 180th day. The associated symptoms such as nausea, vomiting, anorexia, loss of appetite, giddiness, breast tenderness, diarrhea, flatulence, headache, fainting, frequent urination, and fatigue significantly reduced (P < 0.05) at the end of the treatment. The improvement in quality of life and psychological status at the end of 90th day was also significant (P < 0.001). No adverse events were reported during the treatment period. CONCLUSION: SPK and SSR have a positive effect in the treatment of primary dysmenorrhea.

Keywords: Kashtartava, primary dysmenorrhea, Saptasaram Kashaya, Saraswatarishta


How to cite this article:
Surendran ES, Sharma S, Soumya MC, Shivshankar R, Tripathi A, Ota S, Rana R, Sharma BS, Khanduri S, Kumar A, Gupta B, Sudhakar D, Srikanth N, Dhiman KS. Clinical evaluation of the effect of Saptasaram Kashaya and Saraswatarishta in Kashtartava (primary dysmenorrhea). J Res Ayurvedic Sci 2021;5:117-24

How to cite this URL:
Surendran ES, Sharma S, Soumya MC, Shivshankar R, Tripathi A, Ota S, Rana R, Sharma BS, Khanduri S, Kumar A, Gupta B, Sudhakar D, Srikanth N, Dhiman KS. Clinical evaluation of the effect of Saptasaram Kashaya and Saraswatarishta in Kashtartava (primary dysmenorrhea). J Res Ayurvedic Sci [serial online] 2021 [cited 2022 Aug 13];5:117-24. Available from: http://www.jrasccras.com/text.asp?2021/5/3/117/340294




  Introduction Top


Primary dysmenorrhea is defined as painful menstruation without any associated pelvic pathology. Mostly, the patients suffering from primary dysmenorrhea experience associated discomforts such as headache, diarrhea, nausea, and vomiting.[1] This condition usually manifests 6–12 months after menarche with peak prevalence in the late teens or early twenties.[2] It is a leading cause for recurrent non-attendance from school and also responsible for decreased quality of life and sleeping problems in adolescent girls and young women.[3] Prevalence of primary dysmenorrhea varies between 45% and 90% of menstruating women.[4] Although the etiology of primary dysmenorrhea remains less understood, studies show that the overproduction of prostaglandins (PGs) and the resultant hypercontractility of uterus are the cause for pain and cramping.

In situations of primary dysmenorrhea, modern medications such as non-steroidal anti-inflammatory drugs (NSAIDs), antispasmodics, and combination oral contraceptives (COC) are used to relieve pain. NSAIDs act by preventing the excess production of PGs and COCs by preventing ovulation.[5] Over 25% of women experience menstrual discomfort that is resistant to treatment.[6] However, such treatments have limitations, necessitating research on effective medicines which can provide satisfactory relief in pain as well as increase quality of life of patients suffering from primary dysmenorrhea.

In Ayurveda, a disease condition “Kashtartava” has been narrated, which implies primary and secondary dysmenorrhea. This condition is associated with pain during menstruation along with backache, pain in groins, stiffness, etc., but no menstrual abnormality. There may be decrease in the amount of blood flow or the duration of menstruation.[7]Kashtartava is mainly due to vitiation of Apanavata either by obstruction in the passage or due to Dhatukshaya (decrease in Dhatu).[8]Acharya Charaka explains that the reverse flow of vitiated Vata affects the blood flow during menstruation resulting in the painful menses.[9]

Emotional depression and anxiety symptoms are linked to the prevalence of menstrual pain and associated symptoms of dysmenorrhea.[10]Saptasaram Kashaya (SPK) is indicated for pelvic pain associated with menstruation and other causes. Studies have shown that there is a positive correlation between dysmenorrhea and the psychological factors such as stress among the adolescent girls.[11] Dysmenorrhea has a negative impact on mental and physical health of women, resulting in a low quality of life.[12] SSR is indicated in menstrual disorders as well as in the treatment of psychological manifestations. Based on these facts, treatment is required for both physical and mental conditions, and thus the study drugs SPK and Saraswatarishta (SSR) were chosen. The objective of this research is to scientifically validate the effect of SPK and SSR on primary dysmenorrhea (Kashtartava).


  Materials and Methods Top


Study design

The study was a multi-centric, single arm prospective study conducted at the Regional Ayurveda Research Institute (RARI), Thiruvananthapuram and Central Ayurveda Research Institute (CARI), New Delhi. The study was done during the period 2018–2020 and in accordance with the WHO-GCP Guidelines. The study protocol and the consent form were approved by the Institutional Ethics Committees of both the centers. Before enrolling the first participants, the clinical trial was registered in the Clinical Trial Registry of India (CTRI/2016/02/006601).

Sample size calculation

The sample size was calculated on the basis of assumption of detecting a change of 2 points in Visual Analog Scale (VAS) (on a scale of 0–10) pre- and post-treatment based on the results of the previous studies and the standard deviation of 4.5 points with 95% confidence level (α =0.05) and 80% power. The obtained sample size was 39.73. Expecting a dropout rate of 25% in the number of patients to be enrolled in the study, the final sample size was fixed as 50 for per center. The total sample size for two centers is 50 × 2 = 100.

Inclusion criteria

Unmarried girls of age between 13 and 20 years; having normal menstrual cycle (21–35 days) with normal menstrual bleeding (3–7 days) during the last 3 months, but have at least three painful cycles in the last six cycles and intensity of pain during menstruation is more than 40 mm (as per VAS); duration of abdominal pain ≥ 1 day; and those willing to participate in the study were included in the trial.

Exclusion criteria

Patients diagnosed of secondary dysmenorrhea (due to the presence of fibroid, endometriosis, ovarian cyst, pelvic inflammatory disease, and other pathologies); having any systemic illness, diabetes mellitus, hypertension; history of malignancy of pelvic organs; patients on prolonged (>6 weeks) medications such as corticosteroids, antidepressants, anticholinergic drugs, hormone replacement therapy, etc., or any other drugs that may have an influence on the outcome of the study; patients with concurrent hepatic disorder (defined as aspartate amino transferase and/or alanine amino transferase > 2 times the upper normal limit) or renal disorders (defined as serum creatinine greater than the upper limit of laboratory value); Hb% below 10 g; and abnormal thyroid levels were excluded from the study.

Study interventions

The study interventions include SSR and SPK. The administration of SSR was done in the dose of 10 ml mixed with 20 ml of lukewarm water and was advised to be taken at bedtime daily for 3 months. SPK was administered twice daily (morning and evening) before food in the dose of 50 ml along with 6.5 g of Anupan (vehicle) composed of purified asafetida 500 mg, powder of Piper longum L. 500 mg, rock salt 500 mg, and jaggery 5 g. SPK was advised for three menstrual cycles, 7 days in each cycle from the day of onset of menstruation. SPK was given to the participants in the form of powder (bottles of 25 g). The participants were instructed to boil 25 g of powder in 400 ml of water and reduce to 50 ml. The filtrate is to be mixed with Anupan before consumption. The combinations of drug vehicle were packed in sachets in the amount required for 7 days.

Prior and concomitant medications

Before enrollment, it was ensured that no participant was taking any medications as mentioned under exclusion criteria. In case of other acute illnesses, the participants were given rescue medicine and it was noted in the case record form (CRF).

Study procedures

Women complaining of painful menstruation were screened for primary dysmenorrhea in the outpatient departments of the participating institutes. Following the screening, eligible participants were enrolled in the study and directed to the first study visit (Day 0, i.e., baseline). On this day, the clinical signs and symptoms were assessed and recorded in a pre-defined CRF. Assessment of intensity of menstrual pain was done by VAS. Health-related SF-36 (RAND) questionnaire was used to assess the quality of life. The Menstrual Distress Questionnaire and Hamilton Anxiety Scale were used to assess the psychological status. The participants were then given medicines for 1 month [14 bottles of SPK (25 g each)], along with a sachet of Anupan. A bottle of SSR (320 ml) was also given along with drug compliance form (DCF) and a menstrual diary. Participants were clearly instructed to return the used bottles of medicines and the DCF and menstrual diary. In addition, the date for the next visit was provided. Participants’ compliance was ensured by following up with them on a regular basis via personal contact and telephone conversation/electronic communication.

The treatment was continued for 6 months and query was also made for adverse effects of the trial drugs (if any). At the end of the 3 months treatment period, clinical features, psychosomatic status, and quality of life of study participants were assessed. Tests for liver function and renal function were done to confirm the safety of the medicines. Similar clinical evaluation was done after completion of 6 months of treatment. The details of adverse drug reaction and need of concomitant medications at each visit were recorded in the CRF. At each study site, data of all the participants were recorded in the electronic formats designed in MS Excel. For each visit, a nominal travel allowance was given to each enrolled participant.

Laboratory investigations

The laboratory investigations such as routine blood examination, erythrocyte sedimentation rate, random blood sugar, serum cholesterol, liver function test, kidney function test, thyroid function test, and ultrasound sonography (USG abdomen and pelvis) were carried out during screening. All these investigations except thyroid function test were repeated at 90th and 180th day.

Outcome measures

The primary outcome measure was to assess the changes in the nature and intensity of menstrual pain rated as per the VAS scale with scores ranging from 0 to 100. The associated symptoms such as nausea, vomiting, anorexia, constipation, loss of appetite, giddiness, breast tenderness, diarrhea, flatulence, headache, fainting, frequent micturition, and fatigue were assessed by comparing the number of participants who had the symptoms at the commencement of the study to the number who had them at each subsequent visit. The secondary outcome measures were assessment of the changes in the quality of life of the study participants. It was assessed by using the Health Survey-SF-36 Questionnaire (RAND) (time frame: at baseline, 90th, and 180th day) and changes in the psychosomatic status by using the Menstrual Distress Questionnaire and Hamilton Anxiety Scale.

Statistical analysis

The information was gathered in the designed CRFs and also entered into Microsoft Excel. Data were validated for their range and accuracy. The data were analyzed using SPSS software. The quantitative variables are reported as mean±SD, and qualitative variables are reported as n (%). The change in selected variables was assessed across time with the above-mentioned parameters. A paired t-test was used for the comparison of quantitative variables from baseline to endpoints. The McNemar χ2 test was used to compare qualitative variables from baseline to endpoints. The level of significance is set at 5%.


  Results Top


A total of 100 participants were enrolled in the study, out of which 96 completed the trial. Due to non-compliance with the treatment regimen, the remaining four patients were withdrawn from the study.

Demographic profile and socio-economic status of study participants

It was observed that the mean age of the participants was 17 ± 2 years; majority (94%) were students; 43.8% have education up to 10 + 2; mean age of menarche was 12.7 ± 1.2 years, and the mean body weight was 45.5 ± 7.3 kg. All the participants were having normal menstrual cycles with respect to interval and quantity. About 57.3% (n = 55) of participants were having a family history of dysmenorrhea. The details of the baseline characteristics of the enrolled participants are given in [Table 1].
Table 1: Baseline characteristics of the study population (n = 96)

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Effect of the trial drugs on menstrual pain

At baseline, all of the participants complained of dysmenorrhea affecting their daily lives to varying degrees. On the 90th day of assessment, 62.5% of the participants reported having dysmenorrhea. At the end of the 180-day follow-up period, 61.5% had pain during menstruation.

Participants were asked to place a checkmark on a 100-mm horizontal line to indicate the severity of menstrual pain (0=no pain to 100=severe pain) as per VAS. The mean pain score was calculated prior to treatment at baseline, as well as during each month of treatment and follow-up visits. The pain score at each follow-up was compared with the baseline and, a significant difference (P < 0.001) was found.

The study population’s mean VAS score for pain in abdomen during menstruation was reduced with each visit. The mean VAS score at baseline was 90.9 ± 12.3, which decreased to 72 ± 20.3 at 30th day, 49.6 ± 23 at 60th day, 33.4 ± 24 at 90th day, and 23.8 ± 21.3 at 180th day respectively. In all visits, the within-group change from baseline was significant (P < 0.001). The mean decrease from baseline at 90th day was 57.5 (95% CI 52.4–62.6), which was maintained in the post-treatment period [67.1 (95% CI 62.1–72.2)] at 180th day. During the menstrual cycle, the similar results were observed in low backache and pain in the lower limbs [Figure 1].
Figure 1: The decreasing trend in the VAS of pain in dysmenorrhoea

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The associated symptoms such as nausea, vomiting, anorexia, constipation, loss of appetite, giddiness, breast tenderness, diarrhea, flatulence, headache, fainting, frequent urination, and fatigue also showed considerable relief from the baseline [Table 2].
Table 2: Improvement in the associated symptoms of menstruation with the study medicines

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Effect on the psychological status of the participants

Both the Menstrual Distress Questionnaire Score and Hamilton Anxiety Scale Score improved from the baseline and the improvement was found to be statistically significant (P < 0.001) [Table 3].
Table 3: Improvement in the psychological status of the participants with the study drugs (n = 96)

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Effect on health-related quality of life

In the current study, the score obtained on the various domains of SF-36 scales was observed to be improved at the end of 90th day and the effect seen was also statistically significant (P < 0.001) [Figure 2].
Figure 2: Effect of trial drugs on quality of life

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Safety evaluation of the study drugs

During the treatment period, no adverse drug reactions (ADRs) or adverse events (AEs) were reported. The safety laboratory parameters, such as the liver and renal function tests, were evaluated at the beginning and end of the treatment (90th day). There was no discernible change in any of these variables.


  Discussion Top


Dysmenorrhea is a major concern for females, especially those in their adolescent years. Adolescents account for 20.9% of India’s total population, with girls accounting for 47.3% (2011 Census, India). The purpose of the present study was to evaluate the effect of the study drugs SPK and SSR on primary dysmenorrhea.. The findings revealed a significant reduction in menstrual pain, as well as an improvement in the psychological status and quality of life of the participants. It is also observed that pain relief obtained during the treatment period also lasted for a long time during the follow-up period without drug intervention.

Previous research has found a link between a family history and the condition, dysmenorrhea.[13] The current study found that 57.3% of the participants had a family history of dysmenorrhea. In our study, 89% of the participants had scant menstrual bleeding, which was not matching with the findings of a previous study, which found that girls who had menstrual bleeding for more than 5 days had higher chance of getting dysmenorrhea.[14] Pain in primary dysmenorrhea is caused mainly due to the dysrhythmic uterine contractions. The decrease in pain tolerance in adolescent girls exacerbates the problem.[15]

According to Ayurveda principles, the normal formation and expulsion of menses are regulated by Vyana, Samana, and Apana Vata.[16] Diet and lifestyle which can vitiate Vata can cause degeneration among Dhatus.[17] Here the term “Dhatu” can be claimed equivalent to body fluids which nourishes vital body organs. The degeneration or malformation of Rasa (~blood plasma), Rakta (blood), and Mamsa (~muscle/membrane/tissue) can affect the normal formation of myometrium, resulting in failure to create effective contractions to expel the menstrual blood. This may further result in increased efforts from myometrium muscular walls causing ischemia and pain in the pelvic region.[18]

SPK is indicated for pain at vagina, heart/chest, abdomen, low back, and pelvis regions.[19] Its action is narrated as a quick reliver of pain. Hence, it can be considered as treatment option for managing pain, the primary dysmenorrhea. To assess its pain-reliving action, its administration was limited to the time of the menstruation period. Its ingredients are Varshabhu (Boerhaavia diffusa Linn.), Vilva (Aegle marmelose Linn.), Khalva (Dolichos biflorus L. species), Urubu (Ricinus communis L.), Sahachara (Barleria prionitis L.), Sunthi (Zingiber officinale L.), and Angimantha (Premna integrifolia Linn.).

Most of the ingredients are having digestive, carminative, analgesic, anti-inflammatory, channel cleansing, Vatakaphasamana (alleviation of Vata and Kapha), laxative, and blood purifier properties. Thus the formulation SPK can help in breaking the pathogenesis by normalizing the functions of Apana vayu, cleansing the channels as well as removing the obstacles related to menses, which further resulted in providing considerable pain relief. Eranda (R. communis L.) is one of the ingredients in SPK, which can bring about contractile responses in the myometrium.[20] The ingredient B. diffusa is proven to have anti-inflammatory and analgesic activities.[21]

According to the studies, there is a link between dysmenorrhea and psychological difficulties such as anxiety and depression.[22] Previous research studies suggested that psychological factors should also be considered in addition to medical risks in the evaluation and treatment of primary dysmenorrhea.[23] Another study clearly demonstrated that patients with primary dysmenorrhea experience a number of emotional problems associated with dysmenorrhea.[24] These observations highlight the importance of considering the psychological status of adolescents suffering from primary dysmenorrhea. Thus, improving one’s psychological health may improve one’s dysmenorrhea and vice versa. SSR is a strength promotor, rejuvenator, memory enhancer, and Vatasamaka formulation. Its one indication is management of menstruation-related abnormalities.[25]Brahmi (Bacopa monnieri L.), which is a major ingredient of SSR, is reported to be an effective tranquilizer; it has intellect-promoting and anxiolytic activities that are useful for managing the psychologic disturbances during menstruation in adolescents.[26] In short, SSR reduces the pain associated with menstruation along with the effective management of psychological factors. By appetizer and carminative action, it acts on digestive functions and effectively relieves gastrointestinal symptoms such as decreased appetite, flatulence, constipation, etc. This may further increase nutritional status of the patients. In other words, SSR can effectively manage Dhatukshaya, which is one of the pathological factors in the manifestation of primary dysmenorrhea. The role of SSR in managing the psychological manifestation helps to decrease the pain threshold along with relief to associated somatic symptoms. The results on the laboratory parameters show that both the study drugs are safe for use even for a long period. No adverse events were reported during the study period. These prove the safety of these classical Ayurvedic formulations which are in practice since a long time.


  Conclusion Top


The trial drugs SPK and SSR have a significant effect in reducing the pain associated with primary dysmenorrhea and in improving the psychological status and health-related quality of life in adolescent girls. These findings may further be corroborated through a randomized controlled trial.

Acknowledgments

The authors are thankful to all the study participants for their participation in the study. They also thank all the in-charges and staff of participating centers for providing logistic and technical support during data collection.

Authors’ contribution

All authors are involved in drafting the manuscript or revising critically the important components and approved the final version to be submitted for publication.

Financial support and sponsorship

The authors are thankful to the Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi for providing the financial assistance to conduct this multi-center study.

Conflicts of interest

There are no conflicts of interest.



 
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