| CTRI Number |
CTRI/2019/05/019080 [Registered on: 13/05/2019] Trial Registered Prospectively |
| Last Modified On: |
09/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Aththikkai chooranam in the management of Madhumega avathaigal I-V(Diabetes mellitus & its complications) |
|
Scientific Title of Study
|
A Prospective Open Labelled ,Non-randomised,Phase-II clinical trial of ATHTHIKKAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V(DIABETES MELLITUS & ITS COMPLICATIONS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandraprabhu M |
| Designation |
PG scholar |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
II year PG Scholar
Department of Pothu maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9745196316 |
| Fax |
|
| Email |
chandraprabhu016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD facilities and Central library of Govt Siddha Medical College and Hospital. |
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College and Hospital |
| Address |
Palayamkottai
Tirunelveli
PIN-627002
Tamil nadu |
| 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 |
| Chandraprabhu M |
Govt Siddha Medical College and Hospital |
OP Number 10
PG department of Pothu maruthuvam
Govt Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9745196316
chandraprabhu016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,GSMC Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aththikkai Chooranam |
72mg/Kg/BW BD B/F with buttermilk for 90 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1.Type II DM patients who were previously diagnosed and having uncontrolled or poorly controlled for more than 2 years duration of illness.
2.Even if patient is having any one amo ng the three
a.FBS more than 126mg/dl and within 250mg/dl or
b.PPBS more than 200mg/dl and within 350mg/dl or
c.HbA1c more than 6.5 and within 10
3.Patients with symptoms of polyuria,polydipsia,polyphagia,asthenia,obedsity(mdetabolic syndrome),numbness,tingling sensation, mood changes and irritability,difficulty in concentration
4.Patients willing to give blood and urine sample before and after the treatment.
5.Willing to participate in study and signing consent by fulfilling the condition of proforma |
|
| ExclusionCriteria |
| Details |
1.Type I DM
2.Gestational DM
3.Other specific types of DM
4.Diabetes insipidus
5.Pregnancy
6.Lactating mother
7.Chronic kidney disease
8.Chronic liver disease
9.Ischemic heart disease
10.Other types of neuropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To bring the values of FBS less than 126mg/dl PPBS to less than 200mg/dl and HbA1c to less than 6.5
2.Reduction of the sign and symptoms mentioned in inclusion criteria |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Achieving of optimal BMI
2.Achievin g of optimal blood pressure |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/05/2019 |
| 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="11" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a prospective open labelled, non-randomised ,phase II clinical trial to determine the efficacy and safety of ATHTHIKKAI CHOORANAM in patients with MADHUMEGA AVATHAIGAL I-V(DIABETES MELLITUS AND ITS COMPLICATIONS).The trial drug is processed from unripened fruits of FICUS RACEMOSA. In this clinical trial to be held at GSMC,Palayamkottai 60 patients (30 in OPD +30 in IPD) will be recruited and the trial drug will be administered at the dose of 72 mg/Kg/BW BD B/F along with buttermilk as adjuvant for a period of 90 days.All the study related data will be recorded and documented in a separate file for each patients.In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD,GSMC Palayamkottai. During this trial all the efficacy and safety parameters will be recorded in the CRF. After completion of trial all the study related data will be analysed statistically. |