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

NCT05259735 | Completed

• 1 other identifier: Ayurveda DM Study
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes; Type2Diabetes; Diabetes Mellitus

Keywords

Ayurveda; DiabetesMellitus; ClinicalGuideline

Outcome Measures

Primary Outcomes (2)

• To assess the change in the management of type-2 Diabetes with the introduction of Clinical Guideline

  The assessment will be done in the baseline and the end line by measuring HbA1C

  Assessment will be done from the data of screening until the 6 months

• To assess the change Health related quality of life with the introduction of clinical guideline

  Health related quality of life will be assessed in the baseline and the end line through HRQOL questionnaire

  Assessment will be done from the data of screening until the 6 months

Secondary Outcomes (2)

• To determine the rate of dropout

  From the date of screening until the 6 months

• To determine the number of participants who adhere to the guideline

  From the date of screening until the 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Clinical guideline-based management of T2DM by Ayurvedic practitioners. The clinical guideline will cover topics like diagnostic criteria, blood glucose targets, lifestyle advice, Ayurvedic medicines, monitoring and follow-up (including screening for complications and referral to specialists for complications management). The clinical guideline will make recommendations based on the best available evidence. Ayurvedic practitioners will have at least a 5½ year undergraduate medical degree in Ayurveda. Regular training will be provided to Ayurvedic practitioners (in groups) in the use of clinical guideline which will involve roleplaying and structured and instructive feedback to improve their performance. The trainings will be recorded on the Training Attendance Log and they will be provided a Training Certificate for completing the training.

Combination Product: Clinical Guideline based Management

Comparator

ACTIVE COMPARATOR

Comparator: Currently, no standard clinical guideline is used by Ayurvedic practitioners to manage T2DM in Nepal. Thus, the comparator will be the usual management of T2DM (i.e., without any clinical guideline) by Ayurvedic practitioners. Participants will continue their medications for other systemic diseases, if any.

Other: Comparator

Interventions

Clinical Guideline based Management COMBINATION_PRODUCT

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

Intervention

Comparator OTHER

In this arm usual management of T2DM without any clinical guideline

Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥18 years
• new T2DM patients (i.e., treatment naïve), diagnosed by the participating Ayurvedic practitioner
• able to provide written informed consent.

You may not qualify if:

• Pregnant women
• those with any serious or uncontrolled medical condition (e.g., cancer)
• those currently receiving (or has plans to receive during the study period) any related non-pharmaceutical/pharmaceutical intervention.

Sponsors & Collaborators

• Nepal Health Research Council: lead
• University of Nottingham: collaborator

Study Sites (1)

Nepal Health Research Council

Kathmandu, Bagmati, Nepal

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kaushik Chattopadhyay, MPH

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Pradip Gyanwali, MD

  Nepal Health Research Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Final outcome assessment will be conducted after 6 month for both arms by blind assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Chief

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 2, 2022
• Study Start: July 17, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)