Clinical Study of CV-HFD01 tablets as Adjuvant Therapy in patients with Type 2 DM.

Phase 1

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2019/04/018403

Lead Sponsor: Climic Health Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients between 30-60 (both inclusive) age, both sex.

2. Patients receiving Oral Hypoglycemic Agents as ongoing treatment for Type 2 DM .

3. Hemoglobin A1c (HbA1c) >6.5% and <10% (both inclusive)

4. Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive)

Exclusion Criteria

1. Type 1 diabetes.

2. Under Insulin treatment.

3. Patients with concurrent serious Hepatic Dysfunction (defined asAST and/or ALT >3 times of the upper normal limit) or RenalDysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or otherconcurrent severe disease.

4. Women who are pregnant or lactating

5. Smokers/Alcoholics and/or drug abusers

6. Patient with poorly controlled Hypertension

7. Patients with evidence of malignancy

8. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess change from Baseline in Fasting Plasma Glucose (FPG) to Week 12. <br/ ><br>To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 12. <br/ ><br>Timepoint: To assess change from Baseline in Fasting Plasma Glucose (FPG) to Week 12. <br/ ><br>To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 12. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To evaluate change from Baseline in Haemoglobin A1c (HbA1c) at Week 12 (End of <br/ ><br>study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent <br/ ><br>Subjective assessment in each follow up ie week <br/ ><br>0, 4,8 and 12, regarding improvement of the clinical symptoms, i.e., Polyurea, Polyphagia,Polydypsia and Fatigue associated with type 2 DM. <br/ ><br> <br/ ><br>To evaluate tolerability and safety of CV-HFD01 in patients with Type 2 DM.Timepoint: Percentage change in HbA1c from baseline to end of study Percentage change in observational parameters <br/ ><br>like polydipsia, polyphagia, polyuria and fatigue Assessment of tolerance of CV-HFD01 tablets by patients <br/ ><br>Assessment of global evaluation for overall improvement by physician and subject