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A clinical study to see the effect of an Ayurvedic formulation in piles patients

Phase 2
Completed
Conditions
Health Condition 1: null- Piles ( Haemorrhoids)
Registration Number
CTRI/2014/12/005293
Lead Sponsor
CCRAS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1. Patients of either sex aged 16 â??60 years.

2. Presence of 1st, 2nd& 3rd degree Arsha (Hemorrhoids) confirmed by clinical /proctoscopic / colonoscopic examination (With or without bleeding / painful or painless).

3.Willing and able to participate in the study for 06 weeks

Exclusion Criteria

1.Thrombosed&Strangulated pile mass (Hemorrhoids)

2.Bleeding diathesis

3.Cirrhosis of Liver- Portal hypertension

4.Ulcerative colitis / Crohnâ??s disease

5.Patients with evidence of malignancy

6.Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immunosuppressants, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.

7. Patients suffering from major systemic illness necessitating long term drug etc.

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

9. Patients having uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 120mg/dl).

10. Pregnant/ lactating females.

11. Patients on oral contraceptives.

12. History of hypersensitivity to any of the trial drugs or their ingredients.

13. Patients who have completed participation in any other clinical trial during the past six (06) months.

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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