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Clinical Trials/CTRI/2019/01/017277
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Central Council for Research in Ayurvedic Sciences New Delhi

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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