Effect of Nishatriphala yoga on HbA1c level in Madhumeha (Diabetes Mellitus)

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

• Registration Number: CTRI/2023/09/058064
• Lead Sponsor: Dr Vijaylaxmi B Hiremath

Brief Summary

- *Prameha* is one of the eight *Mahagada. Madhumeha* is one of the types of *VatajaPrameha* involving *Ojas* as its *Dushya*, with cardinal symptoms of *Prbhuta* and *Avila Mutrata*, *Adhika Kshudha*, *Adhika Trishna* and *Dourbalya*.

- *Madhumeha* is corelated with Diabetes Mellitus in contemporary science showing symptoms like polyuria, polydipsia, polyphagia, generalized weakness. It is a metabolic disorder which emerged as an important public health problem globally.

- HbA1c (Glycated haemoglobin) has been a standard test of long-term average blood glucose control. It is universally accepted that higher the HbA1c are associated with greater risk of complication from type II diabetes.

- Hence  expected to have effect over glycaemic index and also helping in reducing HbA1c subsequently with reduction in signs and symptoms.

- *Nishatriphala Yoga*  is selected to asses it’s effect on HbA1c in the management of *Madhumeha.*

- 40 Patients of *Madhumeha* will be selected, subjects shall be pre-screened. Ayurvedic subjective assement parameters of Madhumeha (Type-2 DM) based on Signs and sympotms like bahumutrata, trishnadhikya, adhika kshudha etc.Objective parameters are assessed by gradings of HbA1c and FBS, PPBS.

- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis of results, conclusion will be drawn.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-10
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• • Subjects with classical sign and symptoms of Madhumeha and Type-2 Diabetes Mellitus.
• • HbA1C level more than 6.5%.
• • On-going antidiabetic treatment at least 3 weeks.
• • Patient willing to sign and give consent.

Exclusion Criteria

• • Patient of IDDM (Type-1 DM), Juvenile Diabetes and gestational diabetes mellitus will be excluded.
• • Diabetic Patient with co-morbidities, which are life threatening or interferes with the intervention.
• • Pregnant and Lactating mother will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of trail drug over the classical symptoms of Madhumeha and HbA1c level	30 day 60 day 90 day

Secondary Outcome Measures

Name	Time	Method
Assessment of Safety of Drug and Adverse drug reactions	Aggravation of the symptoms of Madhumeha

Trial Locations

Locations (1)

Padma Ayurvedic Hospital And Research Centre; 🇮🇳 Bagalkot, KARNATAKA, India

Padma Ayurvedic Hospital And Research Centre

🇮🇳Bagalkot, KARNATAKA, India

Dr Vijaylaxmi B Hiremath

Principal investigator

9901589010

tejsangvi2124@gmail.com