Randomized double arm Clinical Trial to evaluate the efficacy of Siddha Varmam Therapy (SVT) among Type II Diabetes Mellitus patients attending Madhumegam Special OPD, SCRU, Tirupati
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects in Age between 30-60 years of both gender
- •Patients having Fasting blood sugar ranging above 100 and below 200 mg/dl
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: 9 months
Secondary Outcomes
- 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.)