| CTRI Number |
CTRI/2026/02/104636 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study Comparing Two Ayurvedic Herbal Pastes with Internal Herbal Medicine for Hyper pigmentation |
|
Scientific Title of Study
|
A randomized double arm comparative clinical study to evaluate the efficacy of Arjuna twak churna lepa and Panchavalkala churna lepa along with Patoladi kashaya in the management of Vyanga vis-a-vis Melasma |
| 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 Ranjini Kuruwatti |
| Designation |
PG Research Scholar |
| Affiliation |
Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli |
| Address |
Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
8792956148 |
| Fax |
|
| Email |
rikuruwatti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli |
| Address |
Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
7259348870 |
| Fax |
|
| Email |
madhukaya4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhusudan Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli |
| Address |
Department of Kayachikitsa Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli
Dharwad
KARNATAKA
580024
India |
| Phone |
7259348870 |
| Fax |
|
| Email |
madhukaya4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ranjini Kuruwatti |
| Address |
Hubli Ayurveda Seva Samitis Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubli 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 Ranjini Kuruwatti |
Ayurveda Mahavidyalaya and hospital |
Department of Kayachikitsa
and Kayachikitsa OPD room no 1
Hubli Ayurveda Seva
Samitis Ayurveda Mahavidyalaya and hospital Heggeri
Extension Hubli 580024
Dharwad
KARNATAKA
Dharwad
KARNATAKA |
8792956148
rikuruwatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidyalaya and hospital Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadara samhita, Procedure details: Powdered Arjuna twak is mixed with Makshika and applied over the pigmented area then left for 30 minutes )
(1) Medicine Name: Arjuna twak , Reference: Sharangadara samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadara samhita , Procedure details: Powdered Panchavalkala is mixed with Ksheera and applied over the pigmented area then left for 30 minutes )
(1) Medicine Name: Panchavalkala , Reference: Astanga sangraha, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 30 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi kashaya , Reference: Astanga Hrudaya , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi yoga, Reference: Charaka samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with the clinical features of Vyanga and
Subjects with history of not more than one year of onset |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Hyperpigmentation since birth
History of other skin diseases like lupus eczema and psoriasis
Subjects suffering from systemic disorders like HIV HBsAg positive
Use of oral contraceptives hormone replacement therapy or steroids
Allergy to any ingredients used in the intervention
Active acne or other inflammatory facial disorders |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in MASI score along with improvement in shyavata parusha sparsha number of lesions or patches and size of the lesions |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in the classical signs and symptoms of Vyanga such as Daha and Kandu |
30days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
06/03/2026 |
| 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
|
Skin
disorders have a significant impact on physical appearance and psychological wellbeing
with
melasma being one of the most common hyperpigmentation disorders affecting the
face especially in women of reproductive age In
Ayurveda Vyanga is described under Kshudra
Roga
and closely resembles melasma in its clinical presentation
It
is characterized by painless thin dark patches over the face due to vitiation
of Vata and Pitta Dosha with involvement of Rakta and Twak
Conventional
treatments for melasma provide temporary improvement but are often associated
with adverse effects recurrence and high cost creating a need for safe and
effective alternative therapies Ayurveda
offers a comprehensive approach through Koshta Shodhana internal Shamana
therapy and external Lepa application to correct Dosha imbalance and improve
skin complexion
The
present study is a randomized double arm comparative clinical trial designed to
evaluate and compare the efficacy of Arjuna Twak Churna Lepa and Panchavalkala
Churna Lepa administered along with Patoladi Kashaya in the management of
Vyanga corresponding to melasma A
total
of 50
patients
will be included and treated for 30 days with follow up up
to 60 days
Assessment
will be carried out using subjective parameters such as itching and burning
sensation and objective parameters including discoloration roughness number and
size of lesions and MASI score The
study
aims to establish the efficacy safety and comparative effectiveness of these
Ayurvedic treatment modalities in managing melasma and to provide scientific
evidence for their clinical utility |