To test tablets for Diabetes.

An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Shuddhi Dr. Madhumeh tablets in patients suffering from Diabetes - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/02/080640

Enrollment

Registered

2025-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: E109- Type 1 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject from 18 to 65 years of age. 2. Subject suffering from Diabetes with Fasting Blood Glucose level below 200 mg/dl. 3. If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 4. Subject that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study. 5. Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Females that are pregnant, breast feeding, or planning to get pregnant during the study. 2. Subject on insulin. 3. Subject that have participated in any other interventional clinical trial in the previous 90 days. 4. Subject with known sensitivity to any of the constituents of the investigational product.

Design outcomes

Primary

Measure	Time frame
Efficacy of Shuddhi Dr Madhucare Tablets 1. Change in HbA1c 2. Change in CBC 3. Change in Urine RoutineTimepoint: Day 1, Day 90	—

Secondary

Measure	Time frame
study the quality of life by. 1. QOL(SF-36) 2. SGA Timepoint: Day 1, Day 30, Day 60 and Day 90	—

Countries

India

Contacts

Public ContactPuneet Mittal

CCFT Laboratories

puneetmittal@mgcts.org08937015757

Outcome results