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Prospective Pharmaco-epidemiology Study

A prospective open labeled observational study to document the potential safety issues and prescription trends of selected Rasausadhiâ??s in CCRAS -OPDâ??s across India - Pharmaco-epidemiological Study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027526
Enrollment
1980
Registered
2020-09-01
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: I249- Acute ischemic heart disease, unspecified Health Condition 2: N202- Calculus of kidney with calculus of ureter Health Condition 3: J310- Chronic rhinitis Health Condition 4: R509- Fever, unspecified Health Condition 5: K210- Gastro-esophageal reflux disease with esophagitis Health Condition 6: K77- Liver disorders in diseases classified elsewhere Health Condition 7: J452- Mild intermittent asthma Health Condition 8: M199- Osteoarthritis, unspecified site Health Conditio

Interventions

Intervention1: There are 11 Herbo-Mineral classical Medicines such as Laxmi Vilas rasa, Sutasekhar Rasa, Tribhuvankirti Rasa, Swasakuthar Rasa, Chandraprabha Vati, Gandhaka Rasayana, Rasa manikya, Smr

Sponsors

Central Council for Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have normal levels of liver and kidney function tests. 2. Patients willing to participate in the study for a minimum period of 1week to a maximum of 6 weeks.

Exclusion criteria

Exclusion criteria: 1. Presence of renal or hepatic dysfunction. 2. Subjects who have a history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia, Carcinoma etc 3. Subjects with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 4. Uncontrolled Diabetes Mellitus (HbA1C >8) 5. Any concurrent condition (medical, social or behavioral) that, in the opinion of the research team, would preclude or confound acquisition or interpretation of data or delivery of care. 6. Patient having the H/O intake of Rasaoushadhi in the past 6 weeks.

Design outcomes

Primary

MeasureTime frame
Development of an Ayurvedic informatics database of selected Rasausadhiâ??s in terms of clinical safety.Timepoint: 4 months after recruitment of patients

Secondary

MeasureTime frame
Prospective documentation and analysis of information related with prescription trends of selected Rasausadhiâ??s in a structured format to draw the meaningful possible outcomes and conclusions.Timepoint: 4 months after recruitment of patients

Countries

India

Contacts

Public ContactDr Bidhan Mahajon

CCRAS

sharma.vipin@nic.in9899437195

Outcome results

None listed

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