Ayurvedic Management of Ajeerna (Indigestion).

Phase 2

Completed

Conditions: Functional dyspepsia,

Registration Number: CTRI/2020/01/022661

Lead Sponsor: Multani Pharmaceuticals Ltd

Brief Summary: It is an open label single centric, prospective interventional clinical study to evaluate the efficacy of Pachmeena tonic on 50 patients suffering from *Ajeerna* (Indigestion). The study will be conducted in Department of Panchkarma, NIA, Jaipur, Rajasthan.

50 patients of *Ajeerna* (Indigestion) will be randomly selected from OPD, NIA. Pachmeena tonic will be administered to Patients in a dose of 10 ml orally thrice a day before meal with lukewarm water for duration of 15 days. Follow up will be done for 15 days.

The primary outcome measures will be to assess the efficacy of Pachmeena tonic in patients of *Ajeerna* (Indigestion) by assessing Improvement in Acid regurgitation on Day 0, Day 15th and after Follow up. The secondary outcome (other subjective parameters, as per validated symptom severity grading criteria for the patients with *Ajeerna* (Indigestion), developed by Hu WH, Wong YH et al. (J Gasteroenterol Hrpatol 2002; 17(5): 545-51.) will be assessed on Day 0, Day 15 and after Follow up (Day 30). A Performa shall be prepared incorporating the grading criteria for above mentioned parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

Subjects suffering from Ajeerna (Indigestion) and its related signs and symptoms such as fullness, bloating, nausea, gassy discomfort, loss of appetite, spasm and pain in the chest or abdomen for at least on two occasions in the preceding week and having normal hepatic and renal functions (LFT & RFT).

Exclusion Criteria

Subjects with persistent dyspepsia, vomiting, severe epigastric pain unintentional weight loss, iron deficiency anemia, gastro-intestinal bleeding, dysphasia, odynophagia, previous gastric surgery, epigastric mass, suspicious barium meal, peptic ulcer, and NSAID use.
Organic deformity or malignancy of the GI tract, significant systemic and psychological condition (s) which may hamper the study proceedings, conditions requiring immediate surgical intervention, Alcohol or drug abuse, pregnancy and lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Fullness of Stomach	15 Days

Secondary Outcome Measures

Name	Time	Method
Improvement in other subjective parameters	30 Days

Trial Locations

Locations (1): National Institute of Ayurveda
🇮🇳
Jaipur, RAJASTHAN, India
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Gopesh Mangal
Principal investigator
8619849011
gmangal108@gmail.com