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A Clinical Guideline-based Management of Type-2 Diabetes by Ayurvedic Practitioners in Nepal

NCT05259735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2024-02-22

No results posted yet for this study

Summary

T2DM is a complex disorder which has major health, social and economic consequences. Its chronic hyperglycaemia is associated with macro- and micro-vascular complications and even death. The prevalence of T2DM in Nepal is high.

In Nepal, Ayurveda is the dominant traditional medical system and is in use for thousands of years, especially for meeting the primary healthcare needs. Lack of availability of western medical system doctors in rural areas is another reason. In recognition of these facts, the Nepalese government actively promotes Ayurveda and deploys Ayurvedic practitioners in PHCs, often as the main clinical provider.

This is a two-arm, feasibility cluster RCT with blinded outcome assessment and integrated qualitative process evaluation will be conducted in 12 Ayurvedic Primary Health Care Center Participants who are aged 18 years or above, new T2DM patients (i.e., treatment naïve), diagnosed by the participating Ayurvedic practitioner and able to provide written informed consent will be enrolled in the study. Each participant will be involved in the study for six months.

Patient will be assessed for Glycated haemoglobin, Lipid Profile, Physiological parameters like heart rate and pulse rate, Anthropometric parameters, EuroQol-5D-5L

Conditions

Interventions

COMBINATION_PRODUCT

Clinical Guideline based Management

Clinical guidline based management will be done for Type 2 diabetes Mellitus

OTHER

Comparator

In this arm usual management of T2DM without any clinical guideline

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Nepal Health Research Council

    lead OTHER_GOV

Principal Investigators

  • Kaushik Chattopadhyay, MPH · University of Nottingham

  • Pradip Gyanwali, MD · Nepal Health Research Council

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-17
Primary Completion
2024-01-04
Completion
2024-01-04

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05259735 on ClinicalTrials.gov