Management of Grahani Roga (A digestive system disorder like IBS) through Ayurveda Medicine

Phase 2

Completed

Conditions: Health Condition 1: K582- Mixed irritable bowel syndrome

Registration Number: CTRI/2022/10/046792

Lead Sponsor: Dr Vinod Kumar Gautam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

a) Patients having age between 18 – 65 years of either sex.

b) Patients having following symptoms of Grahani Roga (Amavastha) –

1. Atisrishtam Vibaddham Va Dravam (Irregular bowel habits)

2. Ama Mala Pravritti (Sticky stool)

I. Durgandhita Mala Pravritti (Fowl Smelling stool)

II. Pichchhila Mala Pravritti (Mucous mixed stool)

3. Vibaddha (Constiaption)

4. Dravam (Loose Stool)

5. Udara Shoola (Abdominal pain)

6. Udara Gaurava (Heaviness in abdomen)

7. Ashthi-Parva ruka (Bodyache)

8. Aruchi (Anorexia)

9. Atopa (Bloating)

10. Tikta-Amla Udgar/Vidaha (Acid eructation/Burning sensation in Abdomen)

11. Jwara (Fever)

12. Karshya/ Balakshaya (Weakness)

c) Patient willing to sign the consent form

Exclusion Criteria

a) Age below 18 and above 65 years.

b) Patients suffering from Intestinal tuberculosis, Severe ulceration in stomach.

c) Patients with complicated and chronic Renal or Liver disorders like Nephrotic

syndrome, Hepatitis, Chronic infections and other serious diseases.

d) Patients on prolonged ( >6 weeks) medication with corticosteroids, antidepressants,

anticholinergics, etc. or any other drugs.

e) Pregnant women and lactating mothers.

f) Patients having uncontrolled Diabetes Mellitus or uncontrolled Hypertension.

g) Systemic illness like Tuberculosis, Carcinoma and Endocrine disorders.

h) Patient having the symptoms of Acute M.I., Unstable Angina or CCF.

i) Who have completed participation in other clinical trial during the past six months.

j) Alcoholics and/or drug abusers.

k) Any other condition which the Principal Investigator thinks may jeopardize for study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BOWEL FREQUNCY CONSISTENCY AND MOVEMENT WITH ABDOMINAL PAIN AND BLOATING WILL BE ASSESSED AS PRIMARY OUTCOME ALONG WITH EFFECTIVENESS OF GANDHAKA RASAYANA IN THE MANAGEMENT OF GRAHANI ROGA.Timepoint: 45 DAYS

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the safety, sustainability and adverse drug reaction of trial drug. <br/ ><br>2. To find out the prevalence of symptoms/diseases like IBS, IBD, amoebiasis, ulcerative <br/ ><br>colitis and many other diseases which are having clinical similarities with Grahani Roga <br/ ><br>and effectiveness of trial drug on them.Timepoint: 45 DAYS