Study on the Antidiabetic Benefits of Mehanil Plus Tablets for People with Type 2 Diabetes

A Randomoized, Two-Arm Pilot Study Evaluating Mehanil Plus Tablets in Type Two Diabetes: Biochemical and Quality Parameters Assessment - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070885

Enrollment

Registered

2024-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Individuals diagnosed with hyperglycemia and currently undergoing treatment with Metformin tablets will be considered for study and comparison will be done between the impact of Mehanil plus tablet and placebo in the management of Diabetes type 2

Exclusion criteria

Exclusion criteria: Participants diagnosed with Type 1 Diabetes Mellitus. Participants who are known cases of other chronic systemic illness. Type 2 Diabetes Mellitus patients with complications. Participants who are known cases of psychiatric illness. Pregnancy and Lactating women. Participants having completed any other trail within past 6 months

Design outcomes

Primary

Measure	Time frame
Anticipated favorable outcomes by comparing biochemical parameters at baseline, 21st and end of the study Biochemical parameters: FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID Timepoint: Time points: Baseline, 21st day and 45th day Baseline - FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID 21st day - FBS, OGTT, S insulin level, Lipid profile, C Peptide level ,BMI, HB 45th day - FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID	—

Measure

Time frame

Anticipated favorable outcomes by comparing biochemical parameters at baseline, 21st and end of the study Biochemical parameters: FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID Timepoint: Time points: Baseline, 21st day and 45th day Baseline - FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID 21st day - FBS, OGTT, S insulin level, Lipid profile, C Peptide level ,BMI, HB 45th day - FBS, HbA1C, OGTT, S insulin level, Lipid profile, C Peptide level, HOMA-IR,B,BMI, HB, LFT, RFT, QOLID

—

Secondary

Measure	Time frame
Expected an improvement in Quality of life by comparing baseline & 45th day interrogation by means of Ayurveda symptomatic relief & QOLID questionnaire. Based on the results of the study, effectiveness of Mehanil plus can be provided to the community.Timepoint: 0th day, 21st day, 45th day	—

Countries

India

Contacts

Public ContactDr Dileep K S

Vaidyaratnam Ayurveda Research Institute

ashmarry15@gmail.com7025168188

Outcome results