| CTRI Number |
CTRI/2020/10/028655 [Registered on: 27/10/2020] Trial Registered Prospectively |
| Last Modified On: |
24/10/2020 |
| 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 to study the effect of Siddha medicine Kirambu Chooranam in patients having Karasthamba vatham (peripheral neuritis) |
|
Scientific Title of Study
|
Phase II non-randomized open clinical evaluation of Siddha medicine Kirambu Chooranam for Karasthamba vatham (peripheral neuritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parwin L |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
7708756461 |
| Fax |
|
| Email |
parwin1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
HOD & Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai-600106 Tamilnadu
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parwin L |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu
Post Graduate Department of General Medicine Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
7708757461 |
| Fax |
|
| Email |
parwin1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College 6 Anna Arch road NSK Nagar Arumbakkam Chennai 600106 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu |
| 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 Parwin L |
Arignar Anna Government Hospital of Indian Medicine |
Siddha Department 6 Anna arch road NSK Nagar Arumbakkam Chennai -600106 Tamilnadu
Chennai
TAMIL NADU |
7708756461
parwin1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kirambu chooranam |
1-2 grams of kirambu chooranam is administrated thrice a day with luke warm water for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both gender of Type 2 Diabetic patients who having complaints like tingling and numbness of feet and hands, burning sensation in sole of feet, heat intolerance (unilateral/ bilateral) |
|
| ExclusionCriteria |
| Details |
Patients with known history of hyperthyroidism/ hypothyroidism, drug induced neuropathy, nutritional deficiency neuropathy, renal caused neuropathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by diabetic control level and management of numbness and burning sensation |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
48 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)
|
30/10/2020 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single Non randomized open clinical trial to study the safety and efficacy of Siddha trial drug Kirambu Chooranam .The trial drug is given 1-2 grams thrice a day for 48 days. Clinical trial is conducted after conducting Pre clinical toxicity study. The trial drug Kirambu Chooranam is mentioned in Siroraththina Nadana Kaandam. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |