| CTRI Number |
CTRI/2018/01/011497 [Registered on: 23/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to study the drug Seenthil Sarkkarai on Neerizhivu |
|
Scientific Title of Study
|
A Prospective open labelled Randomized Clinical trial on herbal formulation of “Seenthil Sarkkarai†for the treatment of Iyaneerizhivu
(Chronic Obstructive pulmonary Disease in
patient with Type II Diabetes Mellitus ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarangapany Uthayanan |
| Designation |
PG Student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothu Maruthuvam PG III Year
Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9894468602 |
| Fax |
|
| Email |
dr.uthayanan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD Siddha |
| Designation |
Head of the Department and Professor |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothu Maruthuvam
PG
Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD Siddha |
| Designation |
Head of the Department and Professor |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical college and hospital
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support
Library
Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli 627002 |
| OPD and IPD
Government Siddha Medical college and hospital Palayamkottai
Tirunelveli 627002 |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi |
| Address |
Principal
Government Siddha Medical college and hospital
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 |
| Sarangapany Uthayanan |
Government Siddha Medical College |
Opd room number 10
PG Pothu Maruthuvam
Government Siddha Medical College Palayamkottai
Tirunelveli
TAMIL NADU |
9894468602
dr.uthayanan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Iya Neerizhivu, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Seenthil Sarkkarai |
30 mg/ Kg/BW/daily three times a day With Ghee |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 diabetes mellitus
If yes in any of three
FBS above 110 mg per dl and below and equal 250mg per dl or
PPBS above 160 mg per dl and below and equal 350mg per dl
HbA1c above 6.4 and below 10
Persistent cases of COPD as per the standard key indicators for assessment
FEV1 between above 50 percentage and below 80 percentage of the predicted value
Willing to give blood sample for the investigations
Patients who are mono therapy alone |
|
| ExclusionCriteria |
| Details |
Age below 40 and above 70
Type 1 diabetes mellitus
If yes in any of three
FBS below 109 mg per dl and above and equal 251 mg per dl or
PPBS below 159 mg per dl and above and equal 351 mg per dl
HbA1c below 6.3 and above 10.1
FEV1 below 50 percentage and above 80 percentage of the predicted value
Pregnant woman and plan to pregnant six months
Lactating mother
Chronic kidney disease or Renal failure
Corticosteroid therapy
Chronic active hepatitis or cirrhosis or ascites
Multisystem involvement
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The therapeutic efficacy of trial drug Seenthil Sarkkarai on IYA NEERIZHIVU |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parameters |
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)
|
06/04/2017 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prospective open labelled randomized phase II clinical trial to evaluate the therapeutic efficacy of herbal formulation of seenthil sarkkarai for the treatment of IYA NEERIZHIVU 130mg kg BW daily three time per day with ghee for 90 days in 40 patients during the trial period of 12 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic eficacy of trial drug Seenthil Sakkarai on IYA NEERIZHIVU The Secondary outcome will be the evaluation of Siddha diagnositc parameters |