| CTRI Number |
CTRI/2025/09/094689 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| 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
|
STUDY TO EVALUATE THE EFFICACY OF AVALGUJADI LEPA AND VAYASYADI LEPA ALONG WITH LODRASAVA IN THE MANAGEMENT OF SHWITRA VIS-A-VIS VITILIGO |
|
Scientific Title of Study
|
A RANDOMIZED DOUBLE ARM COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AVALGUJADI LEPA AND VAYASYADI LEPA ALONG WITH LODRASAVA IN THE MANAGEMENT OF SHWITRA VIS-A-VIS VITILIGO |
| 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 Tejaswini Lohar |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
| Address |
Department of Kayachkitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India
Dharwad
KARNATAKA
580024
India |
| Phone |
8861013367 |
| Fax |
|
| Email |
tejuslmarch18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan Kulkarni |
| Designation |
Associate Professor of dept of kayachikitsa |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
| Address |
Department of Kayachkitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India
Dharwad
KARNATAKA
580024
India |
| Phone |
7259348870 |
| Fax |
|
| Email |
madhukaya4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejaswini Lohar |
| Designation |
PG Scholar |
| Affiliation |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
| Address |
Department of Kayachkitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India
Dharwad
KARNATAKA
580024
India |
| Phone |
8861013367 |
| Fax |
|
| Email |
tejuslmarch18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurveda Mahavidyalaya and Hospital, Heggeri Extension, Hubballi- 580024 |
|
|
Primary Sponsor
|
| Name |
Dr Tejaswini Lohar |
| Address |
Ayurveda Mahavidyalaya and Hopsital, Heggeri Extension, Hubballi- 580024 |
| 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 Tejaswini Lohar |
Ayurveda Mahavidyalaya and Hospital, Hubballi |
Department of Kayachkitsa, OPD No. 1, Ayurveda Mahavidyalaya and Hospital Heggeri Extension, Hubballi-580024
Dharwad
KARNATAKA
580024
India
Dharwad
KARNATAKA |
8861013367
tejuslmarch18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Clearance |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avalgujadi Lepa, Reference: Ashtanga Hridaya Chikitsa Sthana 20/13, Route: Topical, Dosage Form: Lepa Gutika, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vayasyadi Lepa, Reference: Sharangadhara Samhita Uttarakhanda 11/41, Route: Topical, Dosage Form: Lepa Gutika, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodrasava, Reference: Ashtanga Hridaya Chikitsa Sthana 12/25-28, Route: Oral, Dosage Form: Asava, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects presenting with the clinical features of Shwitra(Vitiligo).
2) Subjects of either gender between age group of 15-60 years.
3) Subjects with single or less than 5 localised white patches having surface area less than 6
sq.cm.will be selected.
4) Subjects with history of not more than one year of onset. |
|
| ExclusionCriteria |
| Details |
1) Subjects having patch over the sites like lips, glans penis, ear lobes and nail bed.
2) Subjects associated with Leucoderma, albinism and other skin diseases.
3) Subjects suffering from systemic disorders like uncontrolled Diabetes Mellitus, HIV, HBsAg
positive.
4) Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS
1. Daha (Burning sensation)
OBJECTIVE PARAMETERS
Objective parameters are taken based on the Vitiligo Extent Tensity Index score
1. Colour of patch
2. Size of patch
3. Number of patch |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS
1. Daha (Burning sensation)
OBJECTIVE PARAMETERS
Objective parameters are taken based on the Vitiligo Extent Tensity Index score
1. Colour of patch
2. Size of patch
3. Number of patch |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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="6"
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
|
SAMPLE SIZE:
Minimum of 40 subjects will be selected randomly and categorized into two Groups: Group A
and Group B. GROUP A: SAMPLE SIZE : Minimum of 20 Subjects AMA-PACHANA : Trikatu churna, 3gm with ushnajala
as Anupana, Before food, Twice a day,
till Nirama Avastha attained. SHAMANOUSHADHI : Lodrasava, 15ml with ushnajala as Anupana,
After food,Twice a day for 30 days LEPA PRAYOGA : Avalgujadi Lepa with gomutra for application
Once in a day (morning), for 30 days
GROUP B: SAMPLE SIZE : Minimum of 20 Subjects AMA- PACHANA : Trikatu churna 3gm with ushnajala
as Anupana, Before food,
Twice a day, till Nirama Avastha attained. SHAMANOUSHADHI : Lodrasava,15ml with ushnajala as Anupana,
After food,Twice a day for 30 days LEPA PRAYOGA : Vayasyadi Lepa with ajamutra for application
Once in a day (morning), for 30 days
Total Duration: 30 days Follow up: 1. Follow up during intervention period: On 15th day, 30th day 2. Follow up on completion of the intervention: 45th day, 60th day post treatment
PATHYAPATHYA: Subjects of both Groups will be advised Pathya Apathya. |