| CTRI Number |
CTRI/2025/10/095788 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pracchana karma and aragwadhadi taila application in the treatment of shwitra |
|
Scientific Title of Study
|
Clinical evaluation of pracchana karma and aragwadhadi taila application in the management of shwitra |
| 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 Hemant singh chauhan |
| Designation |
MS PG scholar |
| Affiliation |
vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr |
| Address |
Opd no 5 department of shalya tantra vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9416924363 |
| Fax |
|
| Email |
hemantsinghayurveda1988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elizabeth p john |
| Designation |
MS Ayurveda hod of shalya tantra |
| Affiliation |
vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr |
| Address |
Opd no 5 department of shalya tantra vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr1
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9448345918 |
| Fax |
|
| Email |
elizajhn@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elizabeth p john |
| Designation |
MS Ayurveda hod of shalya tantra |
| Affiliation |
vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr |
| Address |
Opd no 5 department of shalya tantra vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr1
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9448345918 |
| Fax |
|
| Email |
elizajhn@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Pharmacy Vaidya yagya Dutt Sharma mahavidhyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Hemant singh chauhan |
| Address |
Opd no 5 department of shalya tantra ground floor PLRD Hospital , vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
Opd no 5 department of shalya tantra vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hemant Singh chauhan |
Vaidya yagya Dutt Sharma Ayurved mahavidhyalaya |
Room No.5 , Shalya Tantra Department , Ground Floor Vaidya yagya Dutt Sharma ayurveda mahavidhyalaya Khurja Bulandshahr Uttar Pradesh 203131
Bulandshahar
UTTAR PRADESH |
9416924363
hemantsinghayurveda1988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Vaidya yagya Dutt Sharma Ayurved mahavidhyalaya Khurja Bulandshahr |
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: Aragwadhadi taila, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patient with single or multiple patches
2. maximum number of patches 6
3. maximum size in diameter 8cm |
|
| ExclusionCriteria |
| Details |
1. patient below 20 years and above 60years of age
2. patients contraindicated for raktmokshan
3. pregnant and lactating mother
4. generalised vitiligo
5. patches due to burning, chemical explosion etc. and located at region of guhya (genital region), panitala (foot soles and hand soles), oshtha (lips), sarvang(whole body), patches with rakta roma (reddish hair) and samsakta (coalescent)
6. vitiligo associated with other disease like hypothyroidism , anemia ,diabetes, hypertension, tuberculosis, RA, SLE etc.
7. HIV, HCV, VDRL, HBSAG POSITIVE |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Pracchana karma and Aragwadhadi taila on colour of the skin , itching and dryness in vitiligo |
Assessment will be done on 7th , 14th 21st 28th 35th 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life & cosmetic effects |
Assessment of the symptoms on 7th 14th 21st 28th 35th & 45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="0"
Months="9"
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
|
ayurvedic classics have mentioned various modalities and formulation for the management of shwitra . the treatment option mainly aim to remove the aggravated doshas by proper shodhana or bio-purifacatory procedures such as raktmokshana ,. pracchana karma is a method of raktmokshana in which multiple small incisions are made to let out impure blood and is usually adopted as sthanika chiktsa sthanik shodhana in the form of pracchana karma help in removal of vitiated blood as well as allow the locally applied drug to penetrate to the deeper dhatus that is rakt , mamsa, twak and meda . aragwadhadi taila is one of the herbo-mineral formulation mentioned in bhaishajya ratnavali kushtha rog chikitsa |