New Herbal Drug Development for Type-2 Diabetes Mellitus

Evaluation of the efficacy of BGR-34(NBRMAP-DB) in the management of Type-2 Diabetes Mellitus (T2DM) - NBRMAPBHU

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009709

Enrollment

100

Registered

2017-09-11

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: null- As per Exclusion and Inclusion criteria set and approved by Ethical Committee, IMS, BHU, Newly diagnosed patient of Type-2 Diabetes Mellitus will be included in Clinical Trial.

Interventions

Intervention1: BGR-34 herbal formulation: Dried Aqueous Extract and Powder of following constituents was used in preparation of herbal formulation: Aqueous Extract: 1. Daruharidra 1150mg, 2. Vijaysar

Eligibility

Inclusion criteria

Inclusion criteria: a) Newly dignosed Patients of Type -2 Diabetes Mellitus who were never on hypoglycemic medicine. b) Both sex and age range 30-60 years. c) Fasting Blood Glucose >=126 and d) Post Prandial Blood Glucose >=200 and e) HbA1C >=6.5% and

Exclusion criteria

Exclusion criteria: a) Patients of Type -1 Diabetes Mellitus b) Age range 60 years. c) Fasting Blood Glucose >200 mg/dl. d) Post Prandial Blood Glucose >=350 mg/dl. e) HbA1C > 8.5% f) Patients suffering from chronic illness like T.B., Rheumatoid arthritis, diagnosed CHD cases.

Design outcomes

Primary

Measure	Time frame
The development of new investigational drug for management of T2DM is a need and the primary objective of this study to evaluate the efficacy of herbal formulation BGR 34 through phase III clinical trial in management of T2DM.Timepoint: One year from the start of clinical trial registration	—

Secondary

Measure	Time frame
The secondary objective of the project to select the patient for inclusion is Clinical trial study, base line observation for determination of exclusion/inclusion parameters and others to include the subject and follow-up evaluation of efficacy of herbal formulation in compare to control drug. The study will help the sponsor to provide robust data in order to prove the therapeutic efficacy of drug as per claim.Timepoint: 1-3 years would be required for sufficient data on clinical trial study.	—

Measure

Time frame

The secondary objective of the project to select the patient for inclusion is Clinical trial study, base line observation for determination of exclusion/inclusion parameters and others to include the subject and follow-up evaluation of efficacy of herbal formulation in compare to control drug. The study will help the sponsor to provide robust data in order to prove the therapeutic efficacy of drug as per claim.Timepoint: 1-3 years would be required for sufficient data on clinical trial study.

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Countries

India

Contacts

Public ContactProf JS Tripathi

Institute of Medical Sciences, BHU

drjstripathi@rediffmail.com9838706393

Outcome results

None listed

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