To Evaluate the efficacy of Vamana dhauti with and without Shivapalapindi in Amlapitta
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reduce in the sign and symptoms of Amlapitta
Study Overview
Brief Summary
Amlapittais a primary disorder of annavaha strotas, caused by vitiation oftridoshas which leads to mandagni causing vidagdhajirna whichin turns leads to vidahi condition. It is characterized by avipaka,klama, tikta-amlodgara, hrud kanta daha, gaurva, aruchi1.Theabove symptoms resemble gastric esophageal reflux diseases, which has signs andsymptoms of heart burn, regurgitation, nausea, indigestion2.
The prevalence of GERD in India islikely to be between 8 - 19% 3. Mostly it is seen in 2nd decade oflife. Several factors like change in lifestyle in terms of culture, smoking anduse of specific food types have contributed to the increased prevalence of GERDin this rapidly progressing society. Though antacids are the most recommendedtreatment in GERD, it is not permanent treatment to cope up with the currentsituation. The long term use of antacids can bring side effects includingdiarrhoea, constipation, changes in metabolism and build up of magnesium. So, there is need ofevolving more effective treatment which relives human sufferings.
Even though there are hundreds ofmedicinal combination are mentioned in the classics for amlapitta, veryfew of such medicinal measures are proved by clinical study, hence it is a needof hour to explore the efficacy of remaining ones.
Vamana dhauti is one among the shadkarma,which is practiced for the removal of kapha pitta dosha4.It acts over amasaya, which is the prime seat of amlapitta. It neutralizesthe acid balance in stomach and relives the symptoms.
Shivapalapindi contains dravyaslike Patha, Patola, Yava, Chandana, Dhanyaka, Amalaki, Vasa, Lavanga, Tvak, Gaja pippli , Haritaki, Madhu, Sita and Ghrita5, which are kapha-pittaharain nature along with dipana, pachana, anulomana, grahiproperties.
Hence in this study Vamanadhautiand Shivapalapindi are taken as interventions which may help in reducingthe signs & symptoms of amlapitta.
In this regard the study planned – “To Evaluatethe efficacy of Vamana dhautiwith and without Shivapalapindi in Amlapitta†is being undertaken.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects between the age group of 18 to 40 yrs, irrespective of gender, religion, occupation & socio.
- •economic status.
- •Subjects having the Classical symptoms of amlapitta as described in Ayurvedic literature will be included.
Exclusion Criteria
- •Subjects with any other systemic illness like Hypertension, Diabetes mellitus.
- •Previously diagnosed cases of ulceration of stomach, esophagus, and duodenum, CA of G.I tract and crohn’s disease.
- •Subjects who are not fit for Vaman dhauti will be excluded.
- •Pregnant lady & lactating women will be excluded.
Outcomes
Primary Outcomes
Reduce in the sign and symptoms of Amlapitta
Time Frame: 30 days
Secondary Outcomes
- other associated symptoms of amlapitta will reduce.(45 days)