| CTRI Number |
CTRI/2021/01/030317 [Registered on: 07/01/2021] 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 VATHA KARAPPAN CHOORANAM(Internal) and SIVAPPU ENNAI(External)in the Management of skin itching |
|
Scientific Title of Study
|
Clinical Evaluation of the Effect on Oral Administration of VATHA KARAPPAN CHOORANAM along with external Administration of SIVAPPU ENNAI in the Management of VATHA KARAPPAN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR V SINDHU |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai. |
| Address |
IInd yr PG scholar
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7845539622 |
| Fax |
|
| Email |
preethisindhu23@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
Tirunelveli
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 v Sindhu |
| Address |
IInd yr 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 V sindhu |
Government Siddha Medical College and Hospital,Palayamkottai |
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College and Hospital
Palayamkottai
627002
Tirunelveli
TAMIL NADU |
7845539622
preethisindhu23@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: L26||Exfoliative dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
SIVAPPU ENNAI(External administration) |
Apply Oil externally as Need according to the patient severity
Duration 21 days |
| Intervention |
VATHA KARAPPAN CHOORANAM(Oral administration) |
Should be Administrated orally thrice a day after food along with Honey when a period of 21 days.Dosage:500mg-1gram |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subject with any of the following symptoms will be included in the study
1.Severe Itching
2.Erythema
3.Vesicles
4.Oozing
5.Lichenification |
|
| ExclusionCriteria |
| Details |
1.Children above 12 years
2.Fungal Infection
3.Bullous formation in skin
4.Congenital Dermatological disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease the frequency of severe itching,erythema,vesicles ,oozing and other clinical symptoms |
21 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)
|
14/01/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/04/2022 |
|
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)
|
STANDARIZATION OF SIDDHA DRUG FORMULATION VATHA KARAPPAN CHOORANAM FOR THE MANAGEMENT OF VATHA KARAPPAN,2.STANDARIZATION OF SIDDHA DRUG FORMULATION OF NAYURUVI NEI FOR THE MANAGEMENT OF KOKKI PUZHU |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a Single Arm Clinical Trial to determine the safety and efficacy of VATHA KARAPPAN CHOORANAM (Oral administration) along with SIVAPPU ENNAI(External administration) in patients with VATHA KARAPPAN.The outcome will measured by day 1,week 1 week 2, week 3 intervals.During this period if any adverse effect and serious adverse effect will be noticed and referred to pharmacovigilence department in Government siddha medical college and hospital, Palayamkottai and for the management will also be given in department of Kuzhanthai maruthuvam OPD and IPD. After the completion of trial all the study related data will be analysed statistically. |