How to cite this article:
Ramana G, Kachare KB, Chiluveri SK, Rao B. Ayurveda-coded Drug (Ayush-SR) for the Management of Occupational Stress among IT Professionals: A Study Protocol of a Randomized Double-blind Placebo-controlled Clinical Trial. J Res Ayurvedic Sci 2020; 4 (2):51-58.
Background: The IT industry is an important profession now a day, but maximum occupational stress is found in it due to uncertain work environment, shift variations, long working hours, and lack of job security. For the management of occupational stress in IT workers, a clinical study has been undertaken with a coded Ayurvedic medicine well-known for anti-stress activities.
Objective: To assess the clinical efficacy and safety of Ayurveda medicine Ayush-SR (a coded drug) in the management of occupational stress among IT professionals.
Methods/design: It is a prospective, randomized double-blind, two-arm, placebo-controlled clinical study. A total 100 IT professionals (50 in each of the arm) will be selected, based on the study inclusion criteria. Group I will receive Ayush-SR tab 1 g twice a day after food and the control arm will receive placebo 1 g twice a day after food for 90 days. The statistical analysis will be done at the end of the trial period to compare the changes in the assessment parameters from the baseline. The study has been approved by the IEC and also registered in CTRI with registration number CTRI 2019/08/020798.
Outcome measures: The primary outcomes include change in the Occupational Stress Index (OSI) score. Secondary outcomes include changes in WHO Well-being Index (1998 version) and changes in the scores of manasa bhava pareeksha.Discussion: The protocol is designed for finding of better clinical outcome and safety profile in management of occupational stress. If found effective, this drug can be listed in management of occupational stress at clinical practice in terms of better efficacy, safety, and cost-effectiveness intervention. The result will be published in a peer-reviewed journal.
Sudha K Chiluveri,
Ashwin C Chiluveri,
Kishor P Patel,
How to cite this article:
Chiluveri SK, Chiluveri AC, Patel KP, Sharma S. Efficacy and Safety of Ayurveda Interventions for Depression: A Systematic Review Protocol. J Res Ayurvedic Sci 2020; 4 (2):59-64.
Introduction: Depression is a disorder of major public health importance. The widely prescribed antidepressants of modern science are falling short in effectively managing the depression. Recent studies reported that depressive patients prefer to use other treatment options like complementary and alternative medicine (CAM therapies). Although systematic reviews on this topic have been published for CAM therapies; however, exclusive to Ayurveda interventions has not been performed till date. Therefore, the present study is intended to do a systematic review of the published clinical data in view of safety, efficacy, or effectiveness of Ayurvedic interventions in the management of depression and meta-analysis of eligible studies will be carried out, if appropriate.
Materials and methods: A systematic review of randomized controlled trials (RCTs), multiple arms clinical trials, trial quasi-experimental trials (nonrandomized controlled clinical trials and before after studies), and observational studies (case series and case reports) will be performed through databases like PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials: Issue 6 of 12, June 2018), AYUSH Research Portal (Govt. of India), DHARA, Google Scholar, and Online clinical trials registers. Studies published from the date of inception till the date the searches are run will be sought. The selection of the studies, data abstraction, and validations will be performed independently by the reviewers and any disagreements will be discussed by the team with fourth reviewer to reach consensus. Established guidelines for study selection, quality assessment, and narrative synthesis will be followed. Risk of bias assessment will be performed with the help of Cochrane risk-of-bias tool for randomized trials (RoB2) tool for RCTs and risk of bias tool to assess nonrandomized studies of interventions (ROBINS-I) tool for non-RCTs (NRCTs). Results of the study will be narratively synthesized and presented in count, percentage, and frequency and meta-analysis will be planned if they are sufficiently homogeneous. Patients will not be involved in any phase of the study; however, ethical approval has been obtained from the Institutional Ethics Committee.
Dissemination: The systematic review will be published in a peer-reviewed journal and will also be disseminated electronically and in print. The review may guide healthcare practices and policy framing regarding the treatment of depression with Ayurvedic interventions.
Study registration no: PROSPERO-CRD42020139382.
Background: Many drugs are available for the management of eczema but a quick and effective management is still the need of the time. Root bark of Karavira (Nerium oleander L.), a semi-poisonous drug of Ayurveda has been reported for its efficacy in skin disorder. Ayurveda considers Vicharchika (eczema) disease condition, under Kshudrakustha (group of minor skin diseases).
Aim: To study and evaluate the efficacy of Rakta Karavira Taila in the treatment of Vicharchika (eczema) through an open-label clinical trial.
Materials and methods: An open-label clinical trial was performed to assess the effect of Rakta Karavira Taila in Vicharchika. The trial drug was prepared by mixing root bark of red variety of Nerium oleander L. and Sarshapa Taila (mustard oil) following the recommended method of oil preparation in Ayurvedic Formulary of India (AFI). Total 30 patients, diagnosed as Vicharchika, were treated by applying required amount of Rakta Karavira Taila externally twice a day for 28 consecutive days. Response to the treatment in the recruited patients was recorded on a weekly basis and therapeutic effect was evaluated through symptomatic relief.
Results:Rakta Karavira Taila, is an oil preparation, which is effective against all the major clinical symptoms of Vicharchika like Kandu (itching), Pidika (papular eruptions), Vaivarnyata (discoloration), Daha (burning sensation), Vedana (pain), and Rukshata (dryness). The study yields statistically significant results in symptoms like Kandu (itching) (p < 0.001), Vaivarnyata (discoloration) (p < 0.001), and Rukshata (dryness) (p < 0.001).
Conclusion:Rakta Karavira Taila has proven to be effective in reducing the symptoms of Vicharchika, when applied for a period of 28 days.
Pilonidal sinus is a worldwide problem found commonly in young hirsute men. The incidence is observed to be 26/100,000 person with 3:1 male predominance. This disease clinically simulates Nadivrana (K14) described in Ayurveda. Many surgical techniques have been described and performed as a treatment for chronic pilonidal sinus. But up to 40% of patients develop recurrence and surgery may cause loss of the intergluteal tissue and other side effects. A 29-year-old nonsmoker, nonalcoholic male student with complaints of a dimple-like depression on the skin surface at upper part of intergluteal cleft associated with pain while sitting or standing, and intermittent discharge of foul-smelling pus and blood draining from the cleft visited the Outpatient Department of Central Ayurveda Research Institute for Cardiovascular Diseases, New Delhi for Ayurvedic management. On examination, there was swollen hyperemic skin around the area which is tender on palpation with hair protruding from the lesion and one visible sinus tract on the skin of cleft. It was diagnosed as pilonidal sinus. After doing the essential laboratory investigations, Ksharasutra therapy was endeavored to treat this disease under local anesthesia. The Ksharasutra was changed weekly after the initial sitting and an Ayurvedic formulation Triphala Guggulu in a dose of 1 g twice a day for 28 days was given orally and local dressing with Jatyadi Tail was performed daily for 28 days. After 28th day of therapy, the tract was completely cut out and healing was observed. There was complete resolution of symptoms like pain and discharge and the sinus tract also got healed. No side effects or adverse drug reaction was found during the therapy. After complete healing of the tract, the patient was followed up for a period of 180 days, with visits in every 30 days and no occurrence was observed. Hence, this therapy can be practiced safely for the treatment of sacrococcygeal pilonidal sinus.