Clinical & preclinical study of effectivenessof Thiripalathi Kashayam in the treatment of Madhumegam

Pre Clinical and Clinical Evaluation of Safety And Effectiveness of Siddha Formulation Thiripalathi Kashayam in the Management of Madhumegam (Type II Diabetes Mellitus) - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/078862

Enrollment

Registered

2025-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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: 1 Adult men / women / transgender 35 years – 60 years of age. 2 Type II Diabetes mellitus (According to American Diabetes Association criteria 2023) 3 If yes, any one of the three (40) a FBS = 126 mg/dl b PPBS = 200 mg/dl c HbA1C = 7 = 10% 4 Patients who didn’t take medicines for Diabetes at least for the past three months and are willing to take study medication alone.

Exclusion criteria

Exclusion criteria: Age below 35 and above 60 yrs HbA1C less than 7 and more than 10 Pregnancy and breastfeeding

Design outcomes

Primary

Measure	Time frame
1.To test the hypothesis that the study drug produces a decrease of 5mmol/mol (equivalent to 0.5%) change in Plasma HbA1cTimepoint: Baseline and after 4 months	—

Secondary

Measure	Time frame
1. To test the proportion of patients achieving • Serum fasting glucose [= 126 mg/dl] & 2 hr postprandial glucose [= 200 mg/dl] (0-1st day, 15th day, 30th day, 60th day, 90th and 120th day of the treatment compared to baseline) 2. Difference in Insulin resistance assessed using HOMA-IR ([Time frame: Baseline & after 4 months) 3. Changes in Fasting lipid profile (Total serum cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein cholesterol (LDL) & very low density lipoprotein (VLDL) [Time frame: Baseline & after 4 months] 4. Glucose uptake study, alpha amylase and alpha glucosidase inhibitory assays. 5. Generation of standardization data of Thiripalathi Kashayam by as per AYUSH PLIM guidelines Timepoint: Baseline & after 4 months	—

Measure

Time frame

1. To test the proportion of patients achieving • Serum fasting glucose [= 126 mg/dl] & 2 hr postprandial glucose [= 200 mg/dl] (0-1st day, 15th day, 30th day, 60th day, 90th and 120th day of the treatment compared to baseline) 2. Difference in Insulin resistance assessed using HOMA-IR ([Time frame: Baseline & after 4 months) 3. Changes in Fasting lipid profile (Total serum cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein cholesterol (LDL) & very low density lipoprotein (VLDL) [Time frame: Baseline & after 4 months] 4. Glucose uptake study, alpha amylase and alpha glucosidase inhibitory assays. 5. Generation of standardization data of Thiripalathi Kashayam by as per AYUSH PLIM guidelines Timepoint: Baseline & after 4 months

—

Countries

India

Contacts

Public ContactDr Janani Syamaroopa Jnanathapaswini

National Institute of Siddha Tambaram Sanatorium Chennai

drlakshmiramaswamy@gmail.com9025575185

Outcome results