| CTRI Number |
CTRI/2024/05/068174 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial on pathiri ver chooranam in the management of madhumega noi (Diabetes mellitus) among patients attending OPD and IPD of Government Siddha Medical College and Hospital,Palayamkottai |
|
Scientific Title of Study
|
A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Pathiriver chooranam in the management of Madhumega Noi(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 |
ABINAYA T |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
OP number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai,Tirunelveli India 627002
Government Siddha Medical College and Hospital Thiruvananthapuram Palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
636115
India |
| Phone |
9585982005 |
| Fax |
|
| Email |
abinayathenmozhi05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sathish kumar |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College And Hospital |
| Address |
OP number 10,PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital Tiruvananthapuram main road Palayamkottai Tirunelveli India
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli Alias Mehala |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha medical college and Hospital |
| Address |
PG Department of Pothu Maruthuvam Government Siddha Medical College and Hospital Thiruvananthapuram Palayamkottai Tirunelveli 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD facilities and central library of government siddha medical college and hospital,Tiruvananthapuram main road, Palayamkottai, Tirunelveli-627002,Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Government Siddha medical college and Hospital |
| Address |
Government Siddha medical college and Hospital
Tiruvanantpuram main road
Palayamkottai
Tirunelveli-627002, Tamilnadu, India |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Abinaya T |
Government Siddha medical college and Hospital |
PG department of pothu maruthuvam Government Siddha Medical College and Hospital Tiruvananthapuram main road Palayamkottai Tirunelveli-627002,India
Tirunelveli
TAMIL NADU |
9585982005
abinayathenmozhi05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government siddha medical college and hospital, Palayamkottai |
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 |
NIL |
NIL |
| Intervention |
Pathiri ver chooranam |
DOSAGE: 1 to 2 gms (Twice a day orally) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Even if patient is having any one among the three (WHO criteria 2019):
a. FBS above 126 mg/dl and below 250mg/dl or
b. PPBS above 200mg/dl and below 350mg /dl or
c. HbA1c above 6.5 and below 10
2. Patients with symptoms of polyuria, polydipsia , polyphagia, asthenia, nocturia,obesity ( metabolic syndrome) , numbness, tingling sensation, mood changes and irritability, difficulty in concentration.
|
|
| ExclusionCriteria |
| Details |
1.Age below above 34 years and below 60 years
2.Type 1 diabetes mellitus
3.Gestational DM
4.Diabetes insipidus
5.Pregnancy
6.Lactating mother
7.Chronic kidney disease
8.Chronic lever disease
9.Ischemic heart diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing symptoms of Diabetes mellitus and to determine the therapeutic efficacy of Pathiriver chooranam |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various siddha literatures and modern journals.
2.To evaluate Physio Chemical, Phyto Chemical, Bio Chemical analysis.
3.To study the anti-microbial activity for selected micro-organism
4.To evaluate Pharmacological activities
5.To evaluate safety profile for acute and sub-acute toxicity
6.To evaluate modern parametric changes in Madhumegam
7.To evaluate the cell line study of anti-diabetic activity
8.To evaluate siddha parameters and compare the changes in
Madhumegam during trial period.
|
6 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 |
|
Date of First Enrollment (India)
|
25/06/2024 |
| 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="1"
Months="0"
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
|
This is A Prospective, open labelled, single arm,non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Pathiriver chooranam in the management of Madhumega Noi( DiabetesMellitus). Pathiri ver chooranam will be freshly prepared and administered at a dosage of 1 to 2 gms (Twice a day orally) with hot water as adjuvant for 3 months for 40 patients of Diabetes mellitus ( 20 OP AND 20 IP patients). The primary outcome will be to develop evidence support for the effect of Pathiriver chooranam in the management of Madhumegam (Diabetes Mellitus ). The secondary outcome will be to collect various siddha literatures and modern journals, to evaluate Physio Chemical, Phyto Chemical, Bio Chemical analysis, to study the anti-microbial activity for selected micro-organism, to evaluate Pharmacological activities, to evaluate safety profile for acute and sub-acute toxicity, to evaluate modern parametric changes in Madhumegam, to evaluate the cell line study of anti-diabetic activity, to evaluate siddha parameters and compare the changes in Madhumegam during trial period.
|