| CTRI Number |
CTRI/2020/12/029890 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect of siddha classical drug Ilanthai kudineer chooranam for the treatment of Diarrhoea |
|
Scientific Title of Study
|
Clinical evaluation of the effect of Ilanthai kudineer chooranam for the treatment of Kanakazhichal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Vidhya Priyadarshini |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842464849 |
| Fax |
|
| Email |
vidhu0209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Shyamala MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Shyamala MDs |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai.
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002 |
|
|
Primary Sponsor
|
| Name |
Dr M Vidhya Priyadarshini |
| Address |
IIyear PG Scholar, Department of kuzhanthai Maruthuvam,
Government Siddha Medical college and hospital, Palayamkottai,
Tirunelveli-627002
|
| 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 |
| Dr M Vidhya Priyadarshini |
Government siddha medical college and hospital, Palayamkottai |
Department of kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU |
9842464849
vidhu0209@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: K591||Functional diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ilanthai kudineer chooranam |
Dose : 15-30ml
Frequency route of administration : twice a day orally
Duration of the therapy : 5 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
subjects with any of the following symptoms will be included in the study
1.Loose stools
2.Loose stools with mucus
3.Increased temperature
4.Mild dehydration |
|
| ExclusionCriteria |
| Details |
1.Children below 3 years and above 12 years
2.Diarrhoea due to intussesceptions
3.Diarrhoea due to Meckels Diverticulam
4.Lactose Intolerance
5.Moderate and Severe dehydration
6.Abdominal distension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreases the frequency of loose stools, body temperature and other clinical symptoms. |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/12/2020 |
| Date of Study Completion (India) |
14/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
ANALYTICAL SPECIFICATIONS AND BIOCHEMICAL ANALYSIS OF SIDDHA HERBAL MEDICINE ILANTHAI KUDINEER CHOORANAM,
INVITRO CARMINATIVE ACTIVITY OF A POLYHERBAL SIDDHA FORMULATION DHASADEEPAKINI CHOORANAM IN THE TREATMENT OF MAANTHASURAM |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a single arm clinical trial to evaluate the therapeutic efficacy of ILANTHAI KUDINEER CHOORANAM for the treatment of KANAKAZHICHAL. The trial drug will be administered orally at the
dose of 15-30 ml before the food, twice a day for a period of 5 days in 40
patients. The trial period of 24 months will be carrying out in Government Siddha Medical College
and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. |