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Jirakadyarishta in the treatment of Grahani (Irritable Bowel Syndrome)

Phase 2
Completed
Conditions
Health Condition 1: K582- Mixed irritable bowel syndrome
Registration Number
CTRI/2019/08/020763
Lead Sponsor
Central Council for Research in Ayurvedic Sciences CCRAS New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
51
Inclusion Criteria

1.Patients of either sex aged 18-65 years

2.Known cases of Grahani (diagnostic criteria as per classical Ayurvedic parameters)

a) Chronic or recurrent abdominal discomfort or pain

b) Abdominal bloating

c) Constipation

d) Diarrhoea

e) Urgency of bowel movements

f) Feeling of incomplete evacuation

g) Passage of mucus

3.Patients willing to give written informed consent and able to participate for 3 months.

Exclusion Criteria

1.Patients with history of Inflammatory Bowel Disease (IBD), Kochââ?¬•s abdomen, Gluten intolerance.

2.Patients with history of chronic Amoebiasis.

3.Known cases of Diabetes Mellitus.

4.Patients with poorly controlled Hypertension ( >160/100 mmHg)

5.Patients who have history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months

6.Symptomatic patients with clinical evidence of Heart failure

7.Known cases of malignancy

8.Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease (COPD).

9.Women who are planning for conception / pregnant or lactating.

10.H/o hypersensitivity to any of the trial drugs or their ingredients

11.Patients who have completed participation in any other clinical trial during the past three months

12.Any other condition which the Investigator thinks may jeopardize the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the clinical efficacy of Jirakadyarishta by the assessment of Changes in Ayurvedic Parameters of GrahaniTimepoint: at the end of14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and 98th day
Secondary Outcome Measures
NameTimeMethod
To assess the clinical efficacy of Jirakadyarishta by the assessment of Changes in IBS-QOL scoreTimepoint: at the end of 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and 98th day
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