Citation Information :
Mahajon B, Dubey N, Panda AK, Rao BC. Traditional Ayurveda Medicines for the Management of Amlapitta (Functional Dyspepsia): A Study Protocol for a Prospective, Single-arm, Open-label Clinical Trial. J Res Ayurvedic Sci 2019; 3 (2):74-83.
Background:Amlapitta (functional dyspepsia, FD) is experienced as a heterogeneous group of upper abdominal symptoms characterized by upper abdominal colic or discomfort which may also comprise heartburn, bloating, regurgitation, early satiety, anorexia, postprandial fullness, belching, and nausea. Traditional Ayurveda medicines are frequently practiced for FD since long; however, available scientific proof relating to their competence and mechanism of actions are insubstantial. In this article, we report a protocol of a prospective, single-arm, open-label, multicenter clinical study by means of classical Ayurveda formulation to examine the effectiveness, mechanism, and safety of the patients diagnosed with Amlapitta (FD). Materials and methods: Present protocol is a single-arm, open-label multicenter clinical study to find the safety and efficacy of classical Ayurveda formulations Narikela Lavana and Amalakyadi Churna in the management of Amlapitta. A total of 110 patients with Amlapitta will be selected based on the inclusion and exclusion criteria. All the patients will be treated orally; with traditional Ayurveda medicine, i.e., powder Narikela Lavana 2 g, twice daily, before food; and Amalakyadi Churna 3 g, twice daily, after food. The entire participant will undergo 12-week treatment and 2-week follow-up. A total of seven visits will be scheduled for each of the participants, i.e., each one in week 0, 2, 4, 6, 8, 10, and 12. The primary outcomes include changes in FD symptoms in dyspepsia questionnaire; changes in symptoms of Amlapitta disease in Amlapitta symptom rating scale (ASRS) along with satisfactory therapeutic response. The secondary outcomes include disease relapse rate after successful treatment; assessment of quality of life in the participants of FD by the World Health Organization Quality of Life (WHO-QOL) scale; and psychological assessment by Beck\'s depression inventory scoring scale. Therapeutic mechanism outcomes, safety outcomes, and end-point outcomes will also be assessed. Discussion: Present protocol has been designed with expected better clinical outcome and safety profile in dyspepsia patients in addition to reduce relapse rate of disease during posttreatment period. If found effective, the selected drug will be listed in terms of better efficacy, safety, and cost-effective treatment of Amlapitta. The selected drug may lead to a step ahead of better understanding and management of other gastrointestinal disorders. Trial registration: Trial has been registered REF/2019/07/027369. The registration number for this trial is CTRI/2019/09/021133.
Harmon RC, Peura DA. Evaluation and management of dyspepsia. Therap Adv Gastroenterol 2010;3(2):87–98. DOI: 10.1177/1756283X09356590.
Brun R, Kuo B. Functional dyspepsia. Therap Adv Gastroenterol 2010;3(3):145–164. DOI: 10.1177/1756283X10362639.
Gandhi SP, Singh RH. Clinical and demographic profile of amlapitta and parinamasula. Anc Sci Life 1995;15(2):102–109.
Lacy BE, Patel NK. Rome criteria and a diagnostic approach to irritable bowel syndrome. J Clin Med 2017;6(11):99. DOI: 10.3390/jcm6110099.
Hidekazu S. The application of the Rome IV criteria to functional esophago-gastro duodenal disorders in Asia. J Neurogastroenterol Motil 2017;23(3):325–333. DOI: 10.5056/jnm17018.
Acharya S, Panda PK, Acharya G, et al. A comparative clinical trial of Chincha kshara and Kadali kshara on Amlapitta. Ayu 2011;32(4): 494–949. DOI: 10.4103/0974-8520.96122.
Baragi UC, Vyas MK. Clinical evaluation of the efficacy of Dashanga Kwatha Ghana Vati in the management of Urdhwaga Amlapitta (non-ulcer dyspepsia). Ayu 2012;33(2):219–223. DOI: 10.4103/0974-8520.105241.
Shastri A, editor. Sri Govindas's Bhaisajya Ratnavali, Shularogadhikara, ch. 30, Ver. 69–70, 2nd ed. Varanasi: Chaukhambha Sanskrit Series Prakashana; 1969. p. 454.
Nneli RO, Woyike OA. Antiulcerogenic effects of coconut (Cocos nucifera) extract in rats. Phytother Res 2008;22(7):970–972. DOI: 10.1002/ptr.2318.
Lima EB, Sousa CN, Meneses LN, et al. Cocos nucifera (L.) (Arecaceae): a phytochemical and pharmacological review. Braz J Med Biol Res 2015;48(11):953–964. DOI: 10.1590/1414-431x20154773.
Pal S, Ramamurthy A, Mahajon B. Medicinal uses of Amalaki (Indian Gooseberry): a historical review. Int J Sci Res Methodol 2016;5(1): 536–548.
Nath R, Mahajon B, Mandal S, et al. Efficacy of Pippalī (Fruits of Piper longum Linn.) in Grahaniroga: a prospective open label clinical trial. J Ayu Med Sci 2017;2(2):197–203. DOI: 10.5530/jams. 2017.2.13.
Karkon Varnosfaderani S, Hashem-Dabaghian F, Amin G, et al. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: a double-blind, randomized, placebo-controlled clinical trial. J Integr Med 2018;16(2):126–131. DOI: 10.1016/j.joim.2018. 02.008.
Wang YC, Huang TL. Anti-Helicobacter pylori activity of Plumbago zeylanica L. FEMS Immunol Med Microbiol 2005;43(3):407–412. DOI: 10.1016/j.femsim.2004.10.015.
Anonymous, In: The Ayurvedic formulary of India (AFI) (Ministry of Health and Family Welfare, Govt. of India, New Delhi) Part I. 2nd ed., Delhi: The Controller of Publications; 2003. p. 166.
Anonymous, In: The Ayurvedic formulary of India (AFI) Part I. 2nd ed., New Delhi: The Controller of Publications, Ministry of Health and Family Welfare, Govt. of India; 2003. p. 160.
Anonymous, In: The Ayurvedic Pharmacopoeia of India, Part II, vol. I 1st ed., New Delhi: The Controller of Publications, Ministry of Health and Family Welfare, Govt. of India; 2011. p. 57.
Bolino MC, Furia M, Facio L, et al. Functional dyspepsia and the satiety test: its usefulness in clinical practice. Rev Gastroenterol Mex 2013;78(3):127–134. DOI: 10.1016/j.rgmx.2013.06.001.
Kumar HK, Sridurga CH, Rao DB. Clinical efficacy of Baladi Manduram in the management of Amlapitta. Ayu 2017;38(3–4):133–138. DOI: 10.4103/ayu.AYU_201_17.
Mahajan R, Khanna V, Bhardwaj A. Role of Narikela Lavana in the Management of Amlapitta. Int J Res Ayurveda Pharm 2016;7(3):50–52. DOI: 10.7897/2277-4343.073111.
Yadavji Trikamaji Acharya, editor. Charaka Samhita of Agnivesha, Sutrasthana, Sharirasthana, ch. 6, Ver. 9, reprint ed. New Delhi: Rashtriya Sanskrit Sansthana; 2006. p. 330.
Anonymous. Astanga Samgraha with the commentary of Indu Sutrasthana. vol. 1, ch. 13, Ver. 3. New Delhi: Central Council for research in Ayurveda and Siddha (CCRAS); 1991. p. 196.
Pol H, More S, Vyas MK, et al. Fundamental approach in the management of Drava Bahula Amlapitta with Bhringaraja (Eclipta alba). Ayu 2011;32(4):512–517. DOI: 10.4103/0974-8520. 96125.
Shastri BM, editor. Bhavaprakash of Bhavmishra, Shooladhikar, Parinaamshool Chikitsa, Ver. 71–72. Varanasi: Chaukhamba Sanskrit Sansthan; 2006. p. 330.
Shastri KN, editor, Rasa Tarangini of Sadanand Sharma, Ksharavisheshadi vigyaniya, ch. 14, Ver. 123–129. New Delhi: Motilal Banarasidas; 1979. p. 348.
Vaidya PB, Vaidya BS, Vaidya SK. Response to Ayurvedic therapy in the treatment of migraine without aura. Int J Ayurveda Res 2010;1(1):30–36. DOI: 10.4103/0974-7788.59941.