A clinical study to evaluate the efficacy and safety of Ayurvedic medicines in the treatment of Agnimandya (an Ayurvedic disease entity, may be correlated to functional dyspepsia)

Phase 2

• Conditions: Health Condition 1: K30- Functional dyspepsia

• Registration Number: CTRI/2023/06/054028
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either sex with age between 18 and 60 years.

2.Patients having any six sign and symptoms of Agnimandya out of 10 (below

mentioned) along with reduced Abhyavaharan Shakti, (capacity to eat), Jarana

Shakti (capacity to digest), and Ruchi (appetite) for the past one week.

1 Avipaka

2 Aruchi

3 Udaragaurava

4 Shirorogaurava

5 Praseka

6 Chhardi

7 Kasa

8 Shwasa

9 Gatrasada

10 Malavarodha

3.Willing to participate in the study.

Exclusion Criteria

1.Patients of age <18 years and >60 years.

2.Patients in whom Agnimandya is caused due to intake of medicine.

3.Patients having Tikshagni (hyper functioning of digestion and metabolic

activities), and Samagni (moderate Agni)

4.Patients having any established disease of Gastro-intestinal tracts.

5.Immuno-compromised states and patients with systemic infections or known cases

of AIDS, HIV, STD etc.

6.Patients with severe/history of cardiac, hepatic, cerebro-vascular disease,

pulmonary dysfunction, malignancy, chronic uncontrolled systemic diseases or

renal disorder (S. Creatinine >1.2 mg/dl) etc or poorly controlled Hypertension

(Blood pressure more than 160/100mm of Hg), uncontrolled Diabetes Mellitus

(HbA1c>=8), or any other serious medical illness.

7.Patients on medication with corticosteroids or any other drugs that may have an

influence on the outcome of the study.

8.History of hypersensitivity to the trial drug or any of its ingredients.

9.Patients who have completed participation in any other clinical trial during the

past three months.

10.Any other condition, which the Investigator thinks, may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in sign and symptoms of AgnimandyaTimepoint: At Baseline, seventh day, fourteenth day and on day 21

Secondary Outcome Measures

Name	Time	Method
â?¢Change in Agnibala. (Agni Pariksha tool developed by CCRAS) <br/ ><br>â?¢Change in quality of life by using SF-36 Score <br/ ><br>Timepoint: At Baseline, seventh day, fourteenth day and on day 21