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

Clinical Evaluation of Pranada Gutika and Abhayarishta in the management of Arsha ( Haemorrhoids)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005293
Enrollment
120
Registered
2014-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Piles ( Haemorrhoids)

Interventions

Intervention1: 1-Pranada Gutika 2-Abhayarishta: Pranada Gutika - 500 mg tds, orally, after food with lukewarm water for 28 days Abhayarishta- 20 ml BD, orally, after food with lukewarm water for 28 d

Sponsors

CCRAS
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Reduction in the pile mass evident by inspection / proctoscopy (visualperception by physician and photography)Timepoint: Reduction in the pile mass evident by inspection / proctoscopy (visualperception by physician and photography)

Secondary

MeasureTime frame
1. Control of bleeding as assessed by physician. 2.Relief from constipation (subjective through interrogation) 3.Improvement in Quality of Life as assessed by SF-36 ( At baseline, after 28 days and after 42 days ) Timepoint: Time points- Before Treatment and After Treatment Time points- Before Treatment ( At baseline) and After Treatment ( after 28 days)

Countries

India

Contacts

Public ContactDr RG Reddy

R. R. A. Podar Ayurveda Cancer Research Institute (CCRAS)

drrgreddy@yahoo.co.in02224947259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026