Effect of treatment using Takra in the management of Grahani Dosha (Irritable bowel syndrome)

Phase 2/3

Completed

• Conditions: Mixed irritable bowel syndrome. Ayurveda Condition: Grahani Dosha,

• Registration Number: CTRI/2021/01/030781
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

**Introduction:**

Grahani dosha described in classical text books of Ayurveda represents a group ofdisorders of digestive system caused by impairment of Agni. The cardinal features of Grahani dosha explained in the classical text books of Ayurveda,have at most similarities with the clinical features of Irritable Bowel Syndrome (IBS) as describedin contemporary medicine. This is one of the common clinical problems among patients attendinggastroenterology clinics. The main clinical features of this ailment are abdominal pain associatedwith an altered bowel habit (may present with diarrhoea or constipation or intermittently both) inthe absence of any structural pathology . And the management of this disease is having limitationsin the present scenario of the contemporary science. All acharyas highlighted in classical texts which are Laghutrayi’s and Bruhatrayi’s, whichpossess Deepana, Grahi & Laghu Gunasv. Due to Swadu-amla rasa, Sandra-avidahi guna itpacifies Vata Dosha, due to Madhur Vipaka it pacifies Pitta dosha, due Kashay rasa, Ushna andVikashi and Ruksha it pacifies Kapha dosha. So, by looking efficacy of Takra in Grahani whichis useful in practice.



**Objective:**

Primary objective – Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama.

Secondary objective – To improve the quality of life.- Nutritional assessment before and after treatment of patient.



**Methodology:**

Study type: Interventional

clinical studyDesign: Pre-test and Post-test design

Allocation: Single arm

Masking: Open label

Primary Purpose: Treatment

Sample size: 30

Group intervention:

Dadimastakachurna 6gm with 100 ml of Takra

Balbilwa Churna 3gm and Musta Churna 6 gm with 100 ml Takra

Panchasakara Churna with wam water

Duration: 30 days

Followup: 30 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-02
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients irrespective of sex, religion, occupation will be selected for study.
• Patients having pratyatma lakshana of Grahani Dosha especially – Atisrushtam or Ativibadhham or Atidravam malapravritti (altered bowel habits), Trushna, Arochaaka, Vairasya, Praseka, Tamaka, Shoona pada, Shoona kara, Asthi-parva ruja, Chhardi, Jwara, Louha-ama-gandhi tiktamlodgara.
• The patients who are diagnosed with IBS according to standard ROME IV criteria.
• Previously diagnosed case of IBS.
• Able and willing to give written informed consent.

Exclusion Criteria

• Mixed infection with parasites such as round worms, hook worms etc.
• Ulcerative colitis, Crohn’s disease, gastric ulcerations and other inflammatory bowel conditions.
• Infectious disorders like Intestinal tuberculosis etc.
• Patients with evidence of malignancy.
• Patents with diabetes mellitus (FBS >126 mg/dl, PP >200 mg/dl), poorly controlled hypertension, Thyroid disorders and any other autoimmune disorders.
• Amoebic dysentery, acute diarrhoea.
• Lactose intolerance patients.
• Abuse of drug or alcohol.
• Patients on prolonged medication with NSAIDs, analgesics or any other drugs that may have an influence on the outcome of the study.
• History of hypersensitivity to any of the trial drugs or their ingredients.
• Patients who have completed participation in any other clinical trial during the past 6 months which is interfering with the results of Grahani Dosha.
• All the types of atisara, Antraja krimija patients and any other conditions interfering with the results of Grahani Dosha / IBS.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama	0th day, 15th day, 30th day, 60th day

Secondary Outcome Measures

Name	Time	Method
1. Nutritional assessment of patient before and after the treatment.	2. To Improvement the quality of life.

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 Delhi, DELHI, India

All India Institute of Ayurveda

🇮🇳Delhi, DELHI, India

Dr Darshan Mahulkar

Principal investigator

8237789211

darshanmahulkar94@gmail.com