Clinical trial on effect of Bilvashalatu Majja and Apakva Bilvaphala Majja in the patient suffering from irregular bowel habits (Sometime Diarrhea or constipation).

Phase 3

Not yet recruiting

• Conditions: Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH,

• Registration Number: CTRI/2025/05/087826
• Lead Sponsor: Institute of Teaching and Research in Ayurveda

Brief Summary

This trial is randomized clinical trial to evaluate the efficacy of Bilvashalatu Majja Churna compare to Apakvabilvaphala Majja Churna along with standard control drug Kutaja Ghanavati in the management of Grahani roga wsr to IBS. Selected patients will be divided in to three group on basis of computer generated randomization. In this study first group will receive Kutajaghanavati in dosage of 2 tab (250mg each)  empty stomach twice a day for 28 days. While in second and third group will receive Bilvashalatu Majja & Apakvabilvaphala Majja Churna respectively in dosage of 5 gm empty stomach twice a day for 28 days

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-23
• Study Start: 2026-04-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients having cardinal symptom of Grahani roga i.e. Muhur Baddha or Drava Mala pravritti and any two of associated complain i.e. Punahapunah Malapravritti, Bhojanottar Malapravritti, Saphena-Sashabda-Sashoola Malapravritti, Arochaka, Udarashool, Katu.
• Tikatamlodgara will be included for the study Patient must have more than or equal to 2 of Rome IV criteria of IBS associated with abdominal pain on average at least 1 day/week in the last 3 months will be included.

Exclusion Criteria

• 1.Patients suffering from Acute diarrhea, Intestinal T.B., Ulcerative colitis, Gastric and peptic ulcer, Crohn’s disease, any genetic and auto immune GIT disorders.
• 2.Patient suffering from Bleeding per rectum 3.Pregnant women and Lactating mother.
• 4.Uncontrolled systemic disorders like Hypertension (more than 160/100mm-Hg) and Diabetes mellitus (RBS more than 180mg/dl).
• 5.Known cases of Tuberculosis, HIV, VDRL, Hep.
• B positive, COPD etc.
• 6.Patients who have a history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. IBS - Symptom Severity Scale - on 0th, 14th, 28th day.	0th and 28th day
1. Changes in scoring pattern in symptoms of Grahani roga	0th and 28th day

Secondary Outcome Measures

Name	Time	Method
1. Agnibala assessment	2. Number of adverse events will be assessed on the basis of lab investigation.

Trial Locations

Locations (1)

Institute of Teaching and Research in Ayurveda Hospital; 🇮🇳 Jamnagar, GUJARAT, India

Institute of Teaching and Research in Ayurveda Hospital

🇮🇳Jamnagar, GUJARAT, India

Dr Sheetal C Dhamecha

Principal investigator

7802975791

shitaldamecha791@gmail.com