| CTRI Number |
CTRI/2025/01/079807 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Other |
|
Public Title of Study
|
Safed Daag |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study to Evaluate Efficacy of Siddhartak Udvartan with Bakuchi Ghan in Shvitra |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Khalid Abdul Aziz Ambekar |
| Designation |
Professor |
| Affiliation |
SVNH Ayurved College |
| Address |
Kayachikitsa Dept.,SVNH Ayurved College,Shrishivajinagar,Tal-Rahuri,Dist-Ahmednagar
Ahmadnagar
MAHARASHTRA
413706
India |
| Phone |
9881786198 |
| Fax |
|
| Email |
Dockhalid28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikant Gunvantrao Deshmukh |
| Designation |
Principal |
| Affiliation |
CSMSS Ayurved College |
| Address |
Principal,CSMSS Ayurved College, Kanchanwadi, Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
dr.shrikantgdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Khalid Abdul Aziz Ambekar |
| Designation |
Professor |
| Affiliation |
SVNH Ayurved College |
| Address |
Kayachikitsa Dept.,SVNH Ayurved College, Shrishivajinagar,Tal-Rahuri,Dist-Ahmednagar
Ahmadnagar
MAHARASHTRA
413706
India |
| Phone |
9881786198 |
| Fax |
|
| Email |
Dockhalid28@gmail.com |
|
|
Source of Monetary or Material Support
|
| SVNH Ayurved College,Shrishivajinagar,Tal Rahuri Dist Ahmednagar413706 |
|
|
Primary Sponsor
|
| Name |
Mohd Khalid Abdul Aziz Ambekar |
| Address |
Kayachikitsa Dept.,SVNH Ayurved College,Shrishivajinagar,Tal-Rahuri,Dist-Ahmednagar |
| 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 |
| Mohd Khalid Abdul Aziz Ambekar |
SVNH Ayurved College and Hospital |
Kayachikitsa Department,Shrishivajinagar,Tal Rahuri Dist Ahmednagar413706
Ahmadnagar
MAHARASHTRA |
9881786198
Dockhalid28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SVNH Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bakuch ghan, Reference: cha chi 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: - | | 2 | Intervention Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: cha chi 7/91-92, Procedure details: powder of Siddhartak kalp is rub over affected parts with luke warm water for 2min in morning sunlight.Once daily for three months)
| | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bakuchi Ghan, Reference: Cha chi 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: In this group both internal Bakuchi ghan and external Udvartan are used in patients |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients fulfilling the criteria of diagnosis of Shvitra irrespective of sex,religion and economic status.
2.Newly developed patches or macules(within one year).
3.Patients of Shvitra having VASI Score less than 50%. |
|
| ExclusionCriteria |
| Details |
1.Psychotic patients.
2.Whole body affected with Shvitra.
3.Shvitra on lips,on palms of hand,sole of feet and white haired patches.
4.Secondary to burn.
5.On private parts.
6.Pregnancy and lactating mother.
7.Patients having hereditary Shvitra.
8.Post injury Shvitra
9.Patient receiving Allopathic or other treatment for Shvitra.
10.Patient having hypersensitive skin to any external application. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shwet Mandal
1) Colour of lesion-
Grade- 0-Normal
1-Black
2-Red
3-Pink
4-White
2) Shape of lesion-
Grade- 0-Totally cured
1-Reduced to some
extend
2-No change in
shape
|
follow up of all patients will be taken after every 15 days for three months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Criteria
1)Kandu(Itching)-
Grade-
0- No Itching
1- Itching less than 1
hour(Mild)
2- Itching 1-2
hrs(Moderate)
3- Itching more than
2 hrs(severe)
2)Rukshata(Dryness)-
0- No dryness
1- Only roughness of skin
with no fissure, no
scaling and no pain
2- Roughness with
scaling.No fissure,no
pain
3- Roughness, scaling and.
fissure with or without
pain
|
All subjective criterias will be assisted every 15 days for 3 months |
3) Daha-
Grade-
0-No daha
1-Occaisional burning
sensation at lesion
site,not felt during
daily physical activities
and during sleep
2-Continues and bearable
daha but not felt during
daily physical
activities and sleep
3-Continues and unbearable
daha,felt during daily
physical
activities,sleep may or
may not disturbed |
All subjective criterias will be assisted every 15 days for 3 months |
Objective Criteria
1) Lesion margin colour-
Grade-
0-Normal
1-Black
2-Red
3-Pink
4-White
2) Colour of overlying hairs-
Grade-
0- Normal
1-Abnormal(Change in
colour)
3) Location of lesion-
Grade-
0-No lesion
1-Single location
2-2-4 location
3-More than 4 locations |
All objective criterias will be assisted every 15 days for 3 months |
Investigations
Haemogram |
Haemogram will be done before and after study(i.e before and after three months) |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
15/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Vitiligo affects about 0.5%-1% of the total worldwide population.The highest incidence is recorded in India and Mexico. The prevalence of Vitiligo in India is between 0.25% to 4% of dermatology OPD. In Ayurveda Bakuchi (Psoralea Corylifolia) is the main herb in treating Shvitra (Vitiligo). In many patients external use of Bakuchi gives Sunburn type effects, so patients try to avoid its use. Considering above factor present study is undertaken to search alternate to Bakuchi. In present study I have taken "Siddhartak Snan Kalp "(Ref-Charak Chikitsa 7/91-92 Chakrapani tika) for external use in "Udvartan " form. |