| CTRI Number |
CTRI/2018/06/014544 [Registered on: 18/06/2018] Trial Registered Prospectively |
| Last Modified On: |
01/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An open clinical study to evaluate the clinical efficacy of Siddha sasthric formulation UTHAMANI KARUKKU for the treatment of KANA MAANTHAM. |
|
Scientific Title of Study
|
An open clinical study to evaluate the clinical efficacy of siddha sasthric formulation UTHAMANI KARUKKU in the treatment of KANA MAANTHAM. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GSMC/IV-IEC/2017/BR-IV/23/29.05.2017 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDEaswari |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
35/1 Ramaswamy Sannathi Street ,Palayamkottai, Tirunelveli.
Department of Kuzhanthai Maruthuvam, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9094463987 |
| Fax |
|
| Email |
easwaridhanapathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDEaswari |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
35/1 Ramaswamy Sannathi Street ,Palayamkottai, Tirunelveli.
Department of Kuzhanthai Maruthuvam, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9094463987 |
| Fax |
|
| Email |
easwaridhanapathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDKSoundararajan |
| Designation |
Head Of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai.
Department of Kuzhanthai Maruthuvam, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442048801 |
| Fax |
|
| Email |
dr.dks2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai. |
|
|
Primary Sponsor
|
| Name |
DrDEaswari |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrDEaswari |
Government siddha medical college and hospital |
Room No.7, Department of Kuzhanthai Maruthuvam,Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU |
9094463987
easwaridhanapathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Siddha Medical College,Palayamkottai,Tirunelveli-627002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K522||Allergic and dietetic gastroenteritis and colitis, Kana Maantham, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Uthamani karukku |
65mg BD with hot water for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Weight loss
Cough
Fever
Watery nasal discharge
Headache
Diarrhea
Bloating abdomen
Drowsiness |
|
| ExclusionCriteria |
| Details |
Protein Energy Malnutrition
Mesentric Adenitis
Tubercular enteritis
Peritonitis
Severe dehydration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and standardize therapeutic management of kana Maantham with Uthamani Karukku. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the prognosis of Kana Maantham based on Sidhha principles. |
1 year |
|
|
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 3 |
|
Date of First Enrollment (India)
|
20/06/2018 |
| 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="2"
Days="10" |
|
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
|
This study is a randomized,self -controlled , single arm trial to evaluate the efficacy of Uthamani karukku 65 mg given in hot water for 7 days in 40 patients with Kana maantham that will be conducted in Government Siddha Medical College and Hospital tirunelveli district . The primary outcome is to evaluate and standardize therapeutic management , secondary outcome will be prognosis of the disease based on siddha principles. |