Clinical study to evaluate safety and efficacy of Unani formulation Safoof-e-Ziabetus Dulabi in Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/08/020838
- Lead Sponsor
- Central Council for Research in Unani Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
i) Patients of any sex in the age group between 25 and 60 years
ii) Fasting Plasma Glucose levels between 126 and 175 mg/dL
or
Post pandrial Plasma Glucose levels between 200 and 250 mg/dL
(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
or
iii)HbA1C level>=6.5 % and
iv) Presence of any of the following symptoms and signs of diabetes mellitus:
2. Utash Mufrit(Polydipsia)
3. Kasrat al-Bawl (Polyuria)
4. Kasrat al-Ishtiha (Polyphagia)
5. Bawl Layli (Nocturia)
6. Iâ??ya(Fatigue)
7. Naqs al-Wazn (Loss of Weight)
8. Sozish-e-Kaf-e-Dast-o-Pa (Burning sensation in palm and soles)
9. Sadr (Giddiness)
10. Naqs al-Shahwa (Loss of Libido
Any of the following:
1.Subjects with fasting plasma glucose level >175 mg/dl and /or
2.Post-pandrial plasma glucose level >250 mg/dl
3.Subjects on Insulin therapy
4.Diabetes Mellitus-Type I
5.Secondary Diabetes Mellitus
6.Diabetes Mellitus associated with complications of Ketoacidosis.
7.Ischemic Heart Disease/ Hypertension/ Hyperlipidemia
8.Liver disorders
9.Impaired Renal function tests
10.Obese Subjects â?? BMI >30
11.Pregnant and lactating women
12.Any infective disorder requiring long-term treatment
13.Drug addicts/ Alcoholics
14.Malignancy/ Epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Response to Therapy <br/ ><br>Clinical assessment will be done at 2, 4, 6, 8, 10, and 12 weeks and the response to treatment will be assessed using the following parameters: <br/ ><br>1. Reduction in FPG and Postprandial Plasma Glucose (2-h PG) level <br/ ><br>2. Decrease inHbA1c level by â?¥1% as compared to baseline <br/ ><br>Improvement in symptoms of DhayÄ?bÄ«á¹us HÌ£Ä?rr Qism ThÄ?nÄ« (Type 2 Diabetes mellitus) on Visual Analogue Scale (VAS) <br/ ><br>Timepoint: At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessments for safety. <br/ ><br>i)Serious Adverse Event (SAE) <br/ ><br>ii)Adverse Event / Adverse Drug Reaction (AE/ADR) <br/ ><br>iii)Laboratory Abnormalities as AEs <br/ ><br>Haemogram, Liver Function Test(LFT), Kidney Function Test(KFT), Lipid profile, Thyroid profile, Complete Urine Examination (CUE): Routine & Microscopic, Erythrocyte Sedimentation Rate(ESR), Electrocardiogram(ECG) <br/ ><br>Timepoint: The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit i.e At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk and also by investigations (done at week 0 and 12). <br/ ><br>