An open labelled double arm non randomised phase II clinical trial to evaluate the efficacy of keezhkai nelli podi and keezhkai nelli podi with siddhar yoga maruthuva muraigal in the management of Type 2 Diabetes Mellitus

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus with unspecified complications,

• Registration Number: CTRI/2025/05/087234
• Lead Sponsor: Dr M Packia Lakshmi

Brief Summary

This study is an open labelled double armed non-randomized phase II clinical trial to evaluate the efficacy of KEEZHKAI NELLI PODI AND SIDDHAR YOGA MURAIGAL in the management of

MADHUMEGAM (TYPE II DIABETES MELLITUS)The study contain 2 groups and divided into Group I is Keezhkai nelli podi internally and Group II is Keezhkai nelli podi internally along with siddhar yoga Muraigal. Each group contain 20 patients and duration 48 days.The study period is 24 months will be

carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002, Tamilnadu.The outcome will be a positive impact of yoga therapy and medicine in the management of  Madhumegam (Type II Diabetes mellitus).In case of any

adverse events (AE) is noticed and it will be referred to pharmacovigilence department of Further management of patients will be given OPD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

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

Inclusion Criteria

Patients of Non Insulin Dependent Diabetes Mellitus with symptoms of Polyuria Polydipsia Nocturia Polyphagia Blood glucose level FBS greater than 126 mg/dl smaller than and equivalent to 250 mg /dl PPBS greater than 200 mg/dl lesser than equivalent to 350 mg/dl HbA1C greater than 6.5 lesser than and equivalent to 8.Willing to participate in Study and signing consent by fulfilling the condition of Proforma.Patient willing to give blood and urine sample before and after the treatment.

Exclusion Criteria

• Patient with diabetic complications Diabetic foot Nephropathy Neuropathy and Retinopathy Insulin Dependent Diabetes Mellitus .Any other serious Systemic illness.
• Pregnancy and lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study outcome is regulate the blood sugar level	48 days

Secondary Outcome Measures

Name	Time	Method
The positive impact of yoga in the treatment	aspect may be highlighted through this study.

Trial Locations

Locations (1)

GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Tirunelveli, TAMIL NADU, India

GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL

🇮🇳Tirunelveli, TAMIL NADU, India

DR M PACKIA LAKSHMI

Principal investigator

6369360237

bhakiyamalathi@gmail.com