| CTRI Number |
CTRI/2024/06/068320 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Shvitranashan Churna and local application of Karpanpatru oil in Shvitra in Children |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHVITRANASHAN CHURNA(GHANA VATI) ALONG WITH KARPANPATRU OIL(KALPITA YOGA) IN THE MANAGEMENT OF SHVITRA (VITILIGO) IN CHILDREN - SINGLE ARM OPEN LABEL PROSPECTIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandra Prabha Sharma |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
PG Department of kaumarbhritya post graduate institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9079295130 |
| Fax |
|
| Email |
chandraprabha938@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Prabha Sharma |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
PG Department of kaumarbhritya post graduate institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9079295130 |
| Fax |
|
| Email |
chandraprabha938@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish Kumar Singhal |
| Designation |
Associate professor &Head of Department of Kaumarbhritya |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
Room NO.155 PG Department of kaumarbhritya post graduate institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S.R Rajasthan Ayurved University Post Graduate Institute of Ayurveda jodhpur |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda,Jodhpur,Rajasthan |
| Address |
PG Department of Kaumarbhritya, Post Graduate Institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus, kadwad, Jodhpur, Rajasthan |
| 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 Chandra Prabha Sharma |
Post Graduate Institute of Ayurveda |
Department of
Kaumarbhritya (OPD no
4) Post Graduate
Institute of Ayurveda Dr
Sarvepalli
Radhakrishnan
Rajasthan Ayurveda
University Kadwad
Jodhpur Rajasthan
342037
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9079295130
chandraprabha938@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shvitranashan churna, Reference: Ras Ratna Samucchaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: -
| | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Karpanpatru oil, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual between age group of 5 to 16 years of both sexes.
2.Children diagnosed as leucoderma or vitiligo as per contemporary medical sciences or shvitra as per clinical features mentioned in ayurvedic texts. |
|
| ExclusionCriteria |
| Details |
1. Children below 5 and above 16 years of age.
2. Children with Albinism.
3. White anesthetic spots due to leprosy.
4. Patches in genital area, lip area and eyes.
5. Vitiligo patches complicated by eczema.
6. White skin patches of fungal infection.
7. Systemic diseases like- Diabetes mellitus, Anemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of shvitranashan churna (ghana vati) along with local application of karpanpatru oil (kalpita yoga) in the management of shvitra |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve health status of children |
three month (90 days) |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Number of patient - 34 Type of study - Open labelled Drug - Shvitranashan churna ( ghana vati) + Karpanpatru oil (kalpita yoga) Dose - Shvitranashan churna (ghana vati) will be given in two divided dose as per young formula. while Karpanpatru oil will be used for local application on lesions. Anupana - oral medicine will be given with godugdha Route - Shvitranashan churna ( ghana vati) - Oral Route Karpanpatru oil (kalpita yoga) - Local application Randomization - simple Duration of study - 3 month Monitoring - Every fortnightly for 3 months Follow up period - One month after completion of trial i.e. on 120th day. |