Comparative effect of fresh and dry Giloy (Guduchi) in the management of diabetes

Phase 2

• Conditions: Health Condition 1: - Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications

• Registration Number: CTRI/2020/09/028006
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Recently diagnosed (less than 1 year of diabetic history) cases of Type-2 DM and not taking any antidiabetic drug/Insulin since 2 months

2. Including both Pre-diabetes and diabetes cases

Fasting Blood Sugar (FBS) ranges between 100 to 125 mg/dl in pre-diabetes and greater than 126 mg/dl to less than equal to 200 mg/dl in diabetes cases.

Post Prandial Blood Sugar (PPBS) ranges between

140 to 199 mg/dl in Pre-diabetes and greater than 200 mg/dl to less than equal to 350 mg/dl in diabetes cases.

HbA1c ranges between 5.7 % to 6.4 % in Pre-diabetes and greater than equal to 6.5 % to less than equal to 8 % in diabetes cases.

3. Presence of urine sugar

4. Frequency of urination 7 to 10 times per 24 hours and quantity and quantity greater than equal to 2500 ml

5. Accidentally diagnosed cases of Type-2 DM who visit the hospital for other complaints

Exclusion Criteria

1. Cardiovascular disorder with Type-2 DM

2. Malignant and accelerated Hypertensive

3. Pregnant woman and planning to be pregnant within 6 months

4. Lactating mother

5. Secondary Diabetes Mellitus

6. Patients undergoing regular treatment for diabetes or any other severe illness

7. CNS Disorder e.g. Encephalopathy

8. Subjects already suffering from the complications of Diabetes (Diabetes Nephropathy, Diabetic retinopathy, Diabetic Neuropathy etc.)

9. Poorly controlled Glycemic status (HbA1c greater than 8%)

10. Concurrent serious hepatic dysfunction (AST or ALT greater than 3 times of upper normal limit)

11. Subjects on steroids, oral contraceptives or estrogen replacement therapy

12. Alcoholics and/or drug abusers

13. H/O hypersensitivity to any trial drug

14. Hypothyroidism or hyperthyroidism

15. Patients on vitamin B supplementation

16. Patients under other clinical trials for more than 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To access clinically the comparative anti-diabetic activity of Aardra (TCa) and Shushka (TCs) Guduchi by assessing the blood glucose level and HbA1c levelTimepoint: 1. Blood Glucose level - 0th day, 15 th day, 30th day, 45 th day, 60 th day, 75 th day, 90th day <br/ ><br> <br/ ><br>2. HbA1c level - 0th day and 90th day

Secondary Outcome Measures

Name	Time	Method
1. Analytical study (HPLC, HPTLC) of TCa and TCs <br/ ><br> <br/ ><br>2. Quality of Life assessment.Timepoint: HPLC and HPTLC - 0th <br/ ><br> <br/ ><br>Quality of Life - 0 and 90 th day