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A clinical trial for development of Ayurvedic management guidelines on diabetes

Not Applicable
Conditions
Health Condition 1: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2021/02/031027
Lead Sponsor
MRC National Institute for Health Research DfID and Wellcome Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Participants should be:

1 aged 18 years and above

2 new T2DM patients (treatment naïve), diagnosed by the participating Ayurvedic practitioner

3 able to provide written informed consent

Exclusion Criteria

1 Pregnant women

2 those with any serious or uncontrolled medical condition (e.g.,cancer)

3 those currently receiving (or has plans to receive during the study period) any related non- pharmaceutical/pharmaceutical intervention

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Baseline characteristics and important parameters such as follow-up will be summarised and compared between the two study arms using numbers and percentages for categorical data and summary measures of mean or median and spread for continuous data. Being a feasibility cluster RCT, it is not adequately powered to detect a difference in outcomes between the two study arms.Timepoint: 12 months
Secondary Outcome Measures
NameTimeMethod
To develop clinical guideline-based management of T2DM by Ayurvedic practitionersTimepoint: 14 months
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