| CTRI Number |
CTRI/2025/01/078862 [Registered on: 16/01/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical & preclinical study of effectivenessof Thiripalathi Kashayam in the treatment of Madhumegam |
|
Scientific Title of Study
|
Pre Clinical and Clinical Evaluation of Safety And Effectiveness of Siddha Formulation Thiripalathi Kashayam in the Management of Madhumegam (Type II Diabetes Mellitus) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Janani Syamaroopa Jnanathapaswini |
| Designation |
Full time PhD Scholar |
| Affiliation |
National Institute of Siddha Tambaram Sanatorium Chennai |
| Address |
Full time PhD scholar,
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9447709745 |
| Fax |
|
| Email |
jsrjtp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Lakshmi kantham |
| Designation |
Guide,Professor Former HOD |
| Affiliation |
National Institute of Siddha Tambaram Sanatorium Chennai |
| Address |
(Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai)
11-A/5,Durga Colony,Main Road,Sembakkam,Chennai-73
Chennai
TAMIL NADU
600073
India |
| Phone |
9025575185 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janani Syamaroopa Jnanathapaswini |
| Designation |
Full time PhD Scholar |
| Affiliation |
National Institute of Siddha Tambaram Sanatorium Chennai |
| Address |
Full time PhD scholar,
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9447709745 |
| Fax |
|
| Email |
jsrjtp@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium Chennai 47 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JANANI SYAMAROOPA JNANATHAPASWINI MD S |
Ayothidoss Pandithar Hospital National Institute of Siddha |
Department of Maruthuvam,Room no 7,8,9 Tambaram sanitorium, Chennai-47
Chennai
TAMIL NADU |
9447709745
jsrjtp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Thiripalathi Kashayam, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 45(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 4 Months, Reference: NA, Route: -, Dosage Form: Kwatha/Kashaya, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
Age below 35 and above 60 yrs
HbA1C less than 7 and more than 10
Pregnancy and breastfeeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To test the hypothesis that the study drug produces a decrease of 5mmol/mol (equivalent to 0.5%) change in Plasma HbA1c |
Baseline and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Baseline & after 4 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of clinical Study: Clinical evaluation of safety and effectiveness
of siddha formulation Thiripalathi Kashayam in
the management
of Madhumegam (Type
II Diabetes mellitus)
STUDY
DESIGN:
Open labelled single centric
phase II clinical study with Siddha herbal formulation Thiripalathi
Kashayam will be conducted in 40 Madhumegam (Type II Diabetes mellitus)
patients.
Study drug dosage:
45 ml 5minutes before
food twice a day
Duration of study drug
administration: 120 days
STUDY PLACE: OPD and IPD of Ayothidoss Pandithar Hospital
National Institute of Siddha, Tambaram sanitorium, Chennai-47
|