Study of efficacy of the Siddha medical (herbal) preparation Mathumeha chooranam” on diabetes mellitus

Phase 2

Conditions: Diabetes mellitus

Registration Number: SLCTR/2015/008

Lead Sponsor: ational Centre for Advanced Studies in Humanities & Social Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete: follow up continuing

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

1. Diagnosed diabetes mellitus
2. Adult patients between 40-70 years of either gender
3. Fasting blood glucose equal or greater than 140mg/dl at recruitment

Exclusion Criteria

1. Diagnosis of other illness such as GIT, Hepatic, Renal, Endocrine disorders according to Siddha diagnostic criteria.
2. Patients on allopathic drugs
3. Presence of complication of the diabetes mellitus (chronic wounds, renal disease, eye disease and peripheral neuropathy)
4. Insulin dependent diabetes mellitus
5. Those unwilling to come for regular follow - up for the entire duration of the study and any subjects considered not eligible according to the researcher’s discretion.
6. Pregnancy
7. Breast feeding
8. Having child bearing potential (Age below 45 who are not on regular contraception)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fasting blood glucose <br>2. Lipid profile<br>3. Alanine amino transferase<br>4. Aspartate amino transferase<br>5. Alkaline Phosphatase<br>6. Total antioxidant capacity of serum by Ferric reducing ability of plasma (FRAP method)<br> [All investigations will be done on the 1st day, to establish a baseline, and then according to the following schedule.<br><br>1. Every ten days for 1 month, then monthly for a total of 3 months<br>2. At the end of 3 months<br>3. At the end of 3 months<br>4. At the end of 3 months<br>5. Monthly for a total of 3 months<br>6. Monthly for a total of 3 months]<br>

Secondary Outcome Measures

Name	Time	Method
Patient symptoms as recorded in patient diary: Thirst, hunger and frequency of urination at day and at night<br>2. Random blood glucose<br>3. Fasting blood glucose<br>4. HbA 1c<br>5. Urine for reducing substances (Benedict’s test)<br>6. Urine for ketones<br> [Day 7, 14, 21, 28, 35, 42 and 49 and then monthly interval up to 3 months]<br>