| CTRI Number |
CTRI/2024/05/067508 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Clinical evaluation of siddha medicine Pavala silasathu parpam for Type II Diabetes mellitus |
|
Scientific Title of Study
|
Single centric Non randomized open clinical trial Phase II in Madhumegam (Type II Diabetes mellitus) with Siddha Medicine Pavala silasathu parpam |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Theenathayalan S |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
8675668879 |
| Fax |
|
| Email |
logansova47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
HOD and Professor |
| Affiliation |
Government Siddha Medical College Chennai. |
| Address |
Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Theenathayalan S |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
8675668879 |
| Fax |
|
| Email |
logansova47@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,Arumbakkam,Chennai |
|
|
Primary Sponsor
|
| Name |
Theenathayalan S |
| Address |
Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai. |
| Type of Sponsor |
Other [Self ] |
|
|
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 Theenathayalan S |
Government Siddha Medical College |
Room No S1,Department of PG Podhu Maruthuvam,Arumbakkam, Chennai
Chennai
TAMIL NADU |
8675668879
logansova47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GSMC,Chennai. |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Pavala silasathu parpam |
This Siddha drug will be given as 130mg,BD dose with Ghee,for 90 days for the management of Type II Diabetes mellitus. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.sex:all genders
2.Polyuria
3.Polydipsia
4.Polyphagia
5.HbA1C-6.5%-8%
|
|
| ExclusionCriteria |
| Details |
1 Pregnant women
2 Lactating mothers
3 Insulin dependent Diabetes mellitus
4 Patient having severe comorbidity like
Cardiovascular disease
5 Diabetic nephropathy
6 Diabetic retinopathy
7 Benign Prostatic hyperplasia
8 Diabetes insipidus
The above criteria will be excluded clinically or based on the available medical reports. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in HbA1C level (atleast 20%) |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical symptoms Polyuria,Polydipsia,Polyphagia &Fatigue |
90 days |
|
|
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 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [logansova47@gmail.com].
- For how long will this data be available start date provided 04-07-2026 and end date provided 30-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Diabetes mellitus is a clinical syndrome characterised by increase in plasma blood glucose (Hyperglycemia). There are two types of diabetes mellitus ,Type I and Type II. Type I Diabetes Mellitus is caused by autoimmune destruction of beta cells in the pancreas, resulting in absolute insulin deficiency, whereas Type I Diabetes Mellitus is due to insulin deficiency or defective action of insulin or both. Chronic hyperglycemia is responsible for diabetes specific microvascular complications affecting the eyes (retinopathy), kidneys (nephropathy) and feet (neuropathy).
India is deemed as the world’s capital of Diabetes. In 2021, approximately 537 million adults (20-79years of age ) are living with diabetes. The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.The diabetic population in the country close to hitting the alarming mark of 69.9 million by2030.
The classical siddha medicine formulation “PAVALA SILASATHU PARPAM†mentioned in "Kannusamy Parambarai Vaithiyam". is indicated for Madhumegam (Type II Diabetes mellitus). Moreover this formulation has anti-diabetic activity that had been proven scientifically .So the author tries to evaluate its efficacy in the management of Type II Diabetes Mellitus in a non-randomised open clinical trial. |