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

An Open Label Clinical trial to assess the Safety and Efficacy of CV-HFD01 tablets as Adjuvant Therapy in patients with Type 2 DM. - CV-HFD01

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018403

Enrollment

Registered

2019-04-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: CV-HFD01 Tablets: CV-HFD01 Tablets are polyherbal formulation intended for its usefulness in managing diabetes type 2. 1 tablet is to be taken twice daily 15 min before each meal. Contr

Eligibility

Inclusion criteria

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

Exclusion criteria

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.)

Design outcomes

Primary

Measure	Time frame
To assess change from Baseline in Fasting Plasma Glucose (FPG) to Week 12. To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 12. Timepoint: To assess change from Baseline in Fasting Plasma Glucose (FPG) to Week 12. To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 12.	—

Secondary

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactMr Prateek Shastrakar

Climic Health Pvt. Ltd.

veenadeo@hotmail.com9371490527

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026