| CTRI Number |
CTRI/2018/03/012756 [Registered on: 22/03/2018] Trial Registered Prospectively |
| Last Modified On: |
21/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to study the drug kadukkai chooranam on Neerizhivu |
|
Scientific Title of Study
|
A prospective open labelled phase II non randomized clinical trial on herbal formulation of "Kadukkai Chooranam" for the treatment of Akkini selathumam (Diabetic Neuropathy) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendram Ajanthan |
| Designation |
PG Student |
| Affiliation |
Government Siddha Medical college and hospital |
| Address |
Department of pothumaruthuvam Room no 10 PG II Year Government Siddha Medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8220898656 |
| Fax |
|
| Email |
raajanth04@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 Pothumaruthuvam 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 Pothumaruthuvam PG
Government Siddha Medical college and hospital Palayamkottai
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 Neelavathy |
| 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 |
| Dr Rajendram Ajanthan |
Government Siddha Medical College |
Opd room number 10 PG Department of Pothumaruthuvam Government Siddha Medical college and hospital Palayamkottai Tirunelveli 627002 Tamilnadu
Tirunelveli
TAMIL NADU |
8220898656
raajanth04@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 |
Akkini Selathumam, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kadukkai Chooranam |
25 mg/kg/BW daily two times with warm water 90 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Type II diabetes mellitus
Previously diagnosed patients which are uncontrolled or poorly controlled for more than 5 years duration of the illness
If yes in any of three
FBS above 126 mg per dl and below and equal 250mg per dl or
PPBS above 200 mg per dl and below and equal 350mg per dl
HbA1c above 6.5 and below 12
Patients with diabetic neuritis complains such as pain numbness tingling sensation of the lower limb
Neuropathic pain scale is less than 4 by 10
The clinical diagnosis was confirmed by of nerve condution studies
|
|
| ExclusionCriteria |
| Details |
B12 deficiency
Severe anaemia
Smoking or alcohol neuropathy
Presence of foot ulcer
Endocrine disorder
Myopathy
Systemic hypertension Angina and heart failure
Type I diabetes mellitus
Pregnancy
Lactating mother
Chronic kidney disease or renal failure
Chronic liver disease
Femoral nerve dysfunction
Mechanical and traumatic nerve injury
|
|
|
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 kadukkai chooranam on AKKINI SELATHUMAM |
The therapeutic efficacy of trial drug kadukkai chooranam on AKKINI SELATHUMAM |
|
|
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)
|
30/03/2018 |
| 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="6"
Days="0" |
|
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 phase II non randomized clinical trial to evaluate the therapeutic efficacy of herbal formulation of kadukkai chooranam for the treatment of AKKINI SELATHUMAM 25mg kg BW daily two time per day with warm water for 90 days in 40 patients during the trial period of 18 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic efficacy of trial drug kadukkai chooranam on akkini selathumam the secondary outcome will be evaluation of siddha diagnostic parameters |