CTRI/2019/01/017277
Not yet recruiting
Phase 2
A clinical study on efficacy and safety of an Ayurvedic Formulation Kutajavaleha in the management of Grahani Roga.
Central Council for Research in Ayurvedic Sciences New Delhi0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Central Council for Research in Ayurvedic Sciences New Delhi
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Known cases of Grahani roga (diagnostic criteria as per classical Ayurvedic Parameters)
- •2\. Patient willing to give written informed consent for participation in the study.
Exclusion Criteria
- •1\.Patients with history of Inflammatory bowel diseases (IBD), Abdominal Koch,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
Outcomes
Primary Outcomes
Not specified
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