| CTRI Number |
CTRI/2022/05/042423 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
11/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the role of Virechana and Bhringrajadi Lepa on Vitiligo in children |
|
Scientific Title of Study
|
A comparative study to evaluate the role of
Virechana and Bhringrajadi Lepa on Shwitra with special reference to Vitiligo in children
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Choukikar |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute of Ayurveda,jaipur Rajasthan |
| Address |
National Institute of Ayurveda, Amer Road Jorawar singh Gate, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8109428870 |
| Fax |
|
| Email |
dryogeshchoukikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinidhi Kumar K |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda,jaipur Rajasthan |
| Address |
Department of Kaumarbhritya, National Institute of Ayurveda, Amer Road Jorawar singh Gate, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877151575 |
| Fax |
|
| Email |
ashanidhiacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh Choukikar |
| Designation |
M.D. Scholar |
| Affiliation |
National Institute of Ayurveda,jaipur Rajasthan |
| Address |
O.P.D.no.5, Ground floor National Institute of Ayurveda, Amer Road Jorawar singh Gate, Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8109428870 |
| Fax |
|
| Email |
dryogeshchoukikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
O.P.D.No.5, Ground Floor,National Institute of Ayurveda, Amer Road Jorawar singh Gate Jaipur Rajasthan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 YOGESH CHOUKIKAR |
National Institute of Ayurveda, Jaipur |
O.P.D.No.5, Ground Floor,National Institute of Ayurveda, Amer Road Jorawar singh Gate Jaipur Rajasthan
Jaipur
RAJASTHAN |
8109428870
dryogeshchoukikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee National Institute of Ayurveda, Jaipur |
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: bhringrajadi lepa, Reference: brihat nighantu ratnakar tvagadosha adhyaya page no. 143, Route: Oral, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Astanga HridayaChikitsa Sthana 20/2, Procedure details: dipan-pachana-abhyantara snehana swedana-virechana-samsarjana karma)
(1) Medicine Name: Trivrata Avaleha, Reference: Astanga Hridaya KalpaSiddhi Sthana 2/9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: od, Duration: 3 Months |
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of either sex between age group of 05 -15 years
2. Children diagnosed as vitiligo as per contemporary medical science or Shwitra as per clinical features mentioned in Ayurvedic texts.
|
|
| ExclusionCriteria |
| Details |
1. Children below 05 and above 15 years of age.
2. Children with Albinism will be excluded.
3. White anesthetic spots, which are characteristic of leprosy will be excluded.
4. Old refractory cases not responding after extensive use of modern medicine will be also excluded.
5. One year old vitiligo patch will be excluded.
6. Patches in genital and lip area will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome Measures- VASI Score |
baseline, 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cosmetic concern of the patient regarding depigmentation of the skin |
baseline, 15th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/05/2022 |
| Date of Study Completion (India) |
23/05/2023 |
| Date of First Enrollment (Global) |
16/05/2022 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
publication sent to journal of ayurveda NIA Jaipur
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Recently rapidly increasing incidences of Shwitra is a challenge for medical world. Vitiligo is the pigmentary disorder of certain hereditary and acquired and autoimmune causes and characterized by depigmented or hypopigmented patches that results from absence or depleted in melanocytes. Pathogenesis of vitiligo points towards autoimmune hypothesis1 and disease may start at any age with increased incidences in first and second decade of life. Based on some dermatological out patient records the incidences are roughly estimated to be between 3-4% in India. However, vitiligo affects the estimated 1-2%of world population which is quite significant2. Present study has been designed to study the role of Samshodhan Karma followed by BhringrajadiLepa, externally, over the discoloured patches in children with subsequent exposure to sunlight. BhringrajadiLepa has been quoted in the classics (Bhrihad Nighantu Ratnakar by Khemraj Shri Krishna Das, Chapter-Tvagadosha, |