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Study to document possible adverse events during Vasti karma

An Observational Study on possible Adverse Events during Vasti Karma A Prospective Pragmatic Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076357
Enrollment
1150
Registered
2024-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue Health Condition 2: G26- Extrapyramidal and movement disorders in diseases classified elsewhere

Interventions

None listed

Sponsors

Central Council for Research in Ayurvedic Sciences (C.C.R.A.S)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who undergo Vasti procedures at the RARI Trivandrum and NARIP Cheruthuruthy during the study period. 2. All types of Vasti procedures, including different types of Kashaya Vasti, Sneha Vasti, Anuvasana Vasti and Matra vasti. 3. Vasti procedures administered to patients of various age groups and genders

Exclusion criteria

Exclusion criteria: • Vasti procedures performed on patients who do not provide informed consent for data collection and adverse event monitoring. • Vasti procedures performed on patients with known allergies or sensitivities to the substances used in the treatment. • Vasti procedures conducted on patients with severe health conditions or critical illnesses that may confound the analysis of adverse events.

Design outcomes

Primary

MeasureTime frame
i.The identification and documentation of all possible adverse events occurring during different types of Vasti proceduresTimepoint: from immediately after vasti administration upto 24 hours

Secondary

MeasureTime frame
i. Categorization of adverse events as major and minor based on their severity. ii. Classification of adverse events by the time of observance: immediate, early-onset, or delayed. iii. Comparison of observed adverse events with references from classical Ayurvedic texts to validate their relevance in contemporary practice. iv. Classification of adverse events based on the specific types of Vasti procedures, such as different Kashaya Vasti, Sneha Vasti, and Anuvasana Vasti. v. Contribution of data to evidence-based practices, guidelines, and quality improvement in Ayurvedic healthcare. vi. Raising awareness about Ayurvedic pharmacovigilance and the importance of monitoring and reporting adverse events in traditional medical practices. Timepoint: At the time of Data analysis

Countries

India

Contacts

Public ContactDr Saniya C K

Regional Ayurveda Research Institute, Trivandrum, Kerala, 695012

saniyack@gmail.com9495166052

Outcome results

None listed

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