Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05259735 |
| Other study ID # |
Ayurveda DM Study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 17, 2022 |
| Est. completion date |
January 4, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Nepal Health Research Council |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
In Nepal, Ayurveda is the dominant traditional medical system and is in use for thousands of
years, especially for meeting the primary healthcare needs. The classical texts are written
in Sanskrit, an ancient language. T2DM is one of the top diseases for which patients consult
Ayurvedic practitioners, and many T2DM patients use Ayurvedic treatments, often from the
beginning and exclusively and throughout their lives.Ayurveda fits their health beliefs and
culture. Acceptability, satisfaction and perceived relief are usually high, especially among
rural, poor, older and tribal populations. Many T2DM patients prefer not to use western
medicines - to avoid the associated side-effects and costs and the mode of administration
like insulin injections. 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.
Strong concerns remain about the sub-optimal T2DM management of many patients, arising from
the unacceptable variations in Ayurvedic clinical practice. The actions to be taken at
different stages of the T2DM care pathway are largely left to the judgment of the individual
Ayurvedic practitioner (including screening for complications and referral to specialists),
resulting in these unacceptable variations. Despite the clinical effectiveness and safety of
several Ayurvedic medicines for managing T2DM found in trial settings, many non-evidence
based herbal and herbo-mineral medicines are prescribed by them in real practice, which can
have serious adverse effects on patients, including heavy metal poisoning. It is exceedingly
difficult for them to be versed with the latest data on most effective and safe Ayurvedic
medicines. One of the major challenges identified by them in their clinical decision-making
process and delivering quality care to T2DM patients is the absence of a good quality
clinical guideline. Its absence forces many of them to blindly follow the claims made by
others or use a 'trial and error' approach.
Faced with similar issues in the western medical system, clinical guidelines have been
effectively deployed in every aspect of clinical care in the last few decades. For example,
clinical trials conducted in English and Mexican primary care settings found that the
introduction of clinical guidelines was effective in managing T2DM. Despite their pervasive
use in the western medical system, their existence in Ayurvedic clinical practice remains
extremely limited. Many stakeholders, including Ayurvedic practitioners, patient groups, the
Nepalese government and WHO, are advocating for good quality clinical guidelines for
Ayurvedic practitioners. Thus, a good quality clinical guideline, based on the best available
evidence, to manage T2DM by Ayurvedic practitioners may address the problems mentioned above.
We searched a range of trial registries and databases, and no study is investigating the
utility of such an intervention for managing T2DM by Ayurvedic practitioners. Thus, there is
a need for a robustly designed pragmatic study to evaluate such an innovative approach.
This is a two-arm, feasibility cluster RCT with blinded outcome assessment and integrated
qualitative process evaluation.
12 Primary Health Centres (PHCs) with at least one Ayurvedic practitioner (most have only
one) for the duration of the study and willing to participate in the study will be randomised
(1:1) to intervention or comparator groups by an independent statistician according to a
computer-generated randomisation schedule. PHCs should be screened for eligibility (PHC
Screening and Randomisation Form) and recorded on the Screening of PHCs Eligible PHCs will be
randomised and provided Site ID.
Ayurvedic practitioners and patients cannot be 'blinded' to group allocation, but the outcome
assessor will be 'blind'.
