Clinical Trial to evaluate the efficacy of Siddha Varmam Therapy (SVT) as an addon therapy to Biomedicine among Diabetes patients

Phase 2

Completed

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2021/02/031407
• Lead Sponsor: Central council for Research in Siddha

Brief Summary

InSiddha system of medicine varmam is one unique method of physical manipulationused for various ailments. In recent years there are many clinical trialsconducted on Varmam therapy to treat diseases such as osteoarthritis, periarthritis,cervical spondylosis, lumbar spondylosis, autism.But still now no attempts were made to prove its effect in Diabetes. This studyaims to validate the SVT in Type II Diabetes Mellitus patients. The objectiveof the study is to evaluate the hypoglycemic activity of Siddha varmam therapy(SVT) among Type II diabetes Mellitus patients in reducing the FBS, PPBS, HbA1c.SVT manipulation done by trained siddha varmam doctor on three days once forthe period of 3 months. The outcome of the study **is assessed by** Efficacyof Siddha Varmam therapy on Type II Diabetes Mellitus patients in reducing theFBS, PPBS, HbA1c at baseline, 90 days of treatment. There are 15 patientsrecruited in Arm 1, 15 patients recruited in arm-2. The study completed itsrecruitment on 02-08-2023.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Study Completion: 2023-02-08
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects in Age between 30-60 years of both gender 2.
• Patients having Fasting blood sugar ranging above 100 and below 200 mg/dl 3.
• HbA1C ranging above 5.5% below 7.5%.

Exclusion Criteria

• Subjects with the age below 30 years and above 60 years are to be excluded from the study.
• Pregnant women and planning to be pregnant within six months and lactating mother.
• Known case of i.
• Malignancy ii.
• Accelerated Hypertension iii.
• Coronary artery disease iv.
• CNS disorders v.
• Type I Diabetes mellitus vi.
• Acute infection or fever vii.
• Chronic viral hepatitis or HIV-infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Efficacy of Siddha Varmam therapy on Type II Diabetes Mellitus patients in reducing the FBS, PPBS, HbA1c at baseline, 30, 60, 90 days of treatment.	9 months

Secondary Outcome Measures

Name	Time	Method
1. Safety of Siddha Varmam therapy on Type II Diabetes Mellitus patients is assessed by comparing Liver function Test and Renal function Test at baseline, 30, 60, 90 days of treatment.	2. Siddha diagnostic tool is validated and tested at baseline, 30, 60, 90 days of treatment.

Trial Locations

Locations (1)

OPD, Siddha Clinical Research Unit, Tirupati.; 🇮🇳 Chittoor, ANDHRA PRADESH, India

OPD, Siddha Clinical Research Unit, Tirupati.

🇮🇳Chittoor, ANDHRA PRADESH, India

Dr S Rajalakshmi

Principal investigator

9585600845

drrajishine@gmail.com