| CTRI Number |
CTRI/2020/02/023625 [Registered on: 27/02/2020] Trial Registered Prospectively |
| Last Modified On: |
04/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical study on Alli Choornam in management of Kapha Neerizhivu noi(Diabetic Peripheral Neuropathy) |
|
Scientific Title of Study
|
A Prospective Open Labelled non randomized phase II Clinical trial on Alli Choornam in management of Kapha Neerizhivu noi(Diabetic Peripheral Neuropathy) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani Syamaroopa Jnanathapaswini |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical college and Hospital |
| Address |
II Year PG Scholar
Department of Pothu Maruthuvam
Government Siddha Medical college and Hospital Palayamkottai Tirunelveli
Palayamkottai
Tamil Nadu
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9447709745 |
| Fax |
|
| Email |
jsrjtp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Manoharan MD S PhD |
| Designation |
Head Of The Department Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College & Hospital Palayamkottai |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College & Hospital Palayamkottai Tirunelveli
Tamilnadu
India
627 002
Government Siddha Medical College & Hospital Palayamkottai Tirunelveli
Tamilnadu
India
627 002
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Manoharan MD S PhD |
| Designation |
Head of the Department Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College and Hospital. |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tamilnadu
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
Tamilnadu
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu 627 002 |
| 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 |
| Janani Syamaroopa Jnanthapaswini |
Government Siddha Medical College |
OPD and IPD of Department of PothuMaruthuvam Government Siddha Medical College and Hospital Palayamkottai 627 002 Tirunelveli
Tirunelveli
TAMIL NADU |
9447709745
jsrjtp@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 |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alli Chooranam |
72 mg/Kg/BW/twice a day A/F
90 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
36.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
Previously diagnosed Type II Diabetes patients having Fasting blood sugar more than 110 mg/dl Postprandial more than 140 mg/dl Random blood sugar 180 mg/dl HbA1C more than 7 with peripheral neuropathy(Sensory) |
|
| ExclusionCriteria |
| Details |
Type I Diabetes mellitus
Diabetes Insipidus
Gestational Diabetes mellitus
Chronic Kidney diseases having S Creatinine more than 2 mg/dl
Motor neuron disease
Presence of foot ulcer
Myopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
During treatment or after treatment reduction of following symptoms
Glucose level within normal limit
HbA1C below 6mg/dl
Reduction in numbness in the limbs
reduction in general tiredness,malaise. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of physicochemical,phytochemical,pharmacological activities of Alli Chooranam.
Evaluation of Siddha parameters (including Envagai thervu) in Kapha Neerizhivu during trial period.
Evaluation of safety profile for acute and Sub acute toxicity of trial drug. |
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)
|
02/03/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Non 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-randomised clinical trial to evaluate the efficacy of Alli Chooranam in the management of Kapha Neerizhivu(Diabetic peripheral neuropathy).The trial drug will be administered at the dose of 72mg/Kg/BW/Twice a day After food for 90 days with luke warm water as adjuvant in 60 patients.The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Playamkottai Tirunelveli Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug Alli Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical actions of the trial drug.In case of any adverse event (AE) is noticed it will be referred to pharmacovigilance department of SCRI. Furthur management of the patient will be given in OPD facility. |