Effectiveness of Vajra Kshara in the management of Amajirnaâ?? A clinical trial

Phase 3

• Conditions: Health Condition 1: K929- Disease of digestive system, unspecified

• Registration Number: CTRI/2021/01/030507
• 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: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients of either sex aged between 18 to 60 years. 2. Patient diagnosed with Ama-Ajirna (as per Ayurvedic classics) having the following symptoms/signs I. ��र�ता(Heaviness of whole body/ abdomen), II. �द��ारश��यथाभ���तमविद��ध�(belching /snoitatcure just after meal), III. �त���ल�द(Nausea), IV. �ण�डश�फ(Swelling of the cheek), V. �वि�� �श�फ(Edema of the periorbital region), VI. स�वाद�वास�यता(sweet taste in mouth)

3. Willing and able to participate for 4 weeks &Subject should be able to provide a written informed consent.

Exclusion Criteria

1. Patients suffering with other type of Ajirna viz. Vishatbdhajirna, Vidagdhajirna, Rasasheshajirna, Dinapakiajirna, Prakrutajirna 2. Subject with Red alarm features (unintentional weight loss, persistent vomiting, dysphagia, hematemesis, melena, fever, or jaundice) 3. Subject with known history of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrettâ??s esophagus) 4. Patients with (Known cases of) Hypertension ( > 130/80mmHg). 5. Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs. 6. Women who are pregnant, lactating, or planning to conceive. 7. Patients on prolonged (>=6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study. 8. History of hypersensitivity to any of the trial drugs or their ingredients. 9. Patients who are judged by the investigators to be unsuitable to participate in the clinical trial (diagnosed psychotic illnesses, substance dependence or alcoholism) 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
1. Changes in symptoms of Amajirna ��र�ता(Heaviness of whole body/ abdomen) �द��ारश��यथाभ���तमविद��ध�(belching /snoitatcure just after meal) �त���ल�द(Nausea) �ण�डश�फ(Swelling of the cheek) �वि�� �श�फ(Edema of the periorbital region) स�वाद�वास�यता(sweet taste in mouth) 2. Satisfactory therapeutic responseTimepoint: 1. baseline, 3rd Day, 7th days, 14th Day <br/ ><br>2. within two week after completion of study medication

Secondary Outcome Measures

Name	Time	Method
a. Psychological Assessment by Perceived Stress Scale(PSS) <br/ ><br> b. Agni assessment through Questionarries preparied by CCRAS. <br/ ><br> c. Disease relapse rate after treatment successTimepoint: a & b. baseline, 3rd Day, 7th days, 14th Day and 28th Day <br/ ><br>c. after 2 weeks of post treatment period