| CTRI Number |
CTRI/2025/03/082223 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study conducted to see the Effect of Vatapatradi Lep and Lodhradi Lepa with Manjisthadi Kwath in Mukhadushika with Special Reference to Acne Vulgaris |
|
Scientific Title of Study
|
An Open Labelled Randomized Comparative Clinical Study
to Evaluatethe Efficacy of Vatapatradi Lepa and Lodhradi Lepa
with Manjisthadi KwathIn Mukhadushika
With Special Reference to Acne Vulgaris
|
| Trial Acronym |
VLLL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KSHITIJA SUNIL CHINDHE |
| Designation |
PG SCHOLAR KAYACHIKITSA |
| Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot |
| Address |
Department of PG studies in kayachikitsa BVVS Ayurveda Medical Colllege And Hospital Bagalkot Karnataka 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
8010644384 |
| Fax |
|
| Email |
Kshitijachindhe98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SS KALYANI |
| Designation |
PROFESSOR |
| Affiliation |
BVVS Ayurveda Medical College And Hospital Bagalkot |
| Address |
Department of PG studies in kayachikitsa BVVS Ayurveda Medical College And Hospital Bagalkot Karnataka 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SS KALYANI |
| Designation |
PROFESSOR |
| Affiliation |
BVVS Ayurveda Medical College And Hospital Bagalkot |
| Address |
Department of PG studies in kayachikitsa BVVS Ayurveda Medical College And Hospital Bagalkot Karnataka 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurveda Medical College And Hospital Bagalkot Karnataka India 587101 |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurveda Medical College And Hospital |
| Address |
BVVS Ayurveda Medical College And Hospital Bagalkot Karnataka 587101 |
| Type of Sponsor |
Private medical college |
|
|
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 KSHITIJA SUNIL CHINDHE |
BVVS Ayurveda Medical College And Hospital |
Department of Kayachikitsa BVVS Ayurveda Medical College And Hospital Bvvs campus Bagalkot Karnataka 587101
Bagalkot
KARNATAKA |
8010644384
Kshitijachindhe98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC BVVS Ayurveda Medical College And Hospital Bagalkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita, Procedure details: Lepa should be applied on the face opposite to the direction of orientation of hair 1/4 angula(0.25mm) thickness as a local application in the morning until the lepa dries for a
duration of 30 days.)
(1) Medicine Name: Vatapatradi lepa, Reference: Basavarajeeyam , Route: Topical, Dosage Form: Lepa Churna, Dose: 00(NA), Frequency: od, Duration: 30 Days(2) Medicine Name: Manjisthadi kwath, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita, Procedure details: Lepa should be applied on the face opposite to the direction of orientation of hair 1/4 angula(0.25mm) thickness as a local application in the morning until the lepa dries for a
duration of 30 days.)
(1) Medicine Name: Lodhradi lepa, Reference: Chakradatta , Route: Topical, Dosage Form: Lepa Churna, Dose: 00(NA), Frequency: od, Duration: 30 Days(2) Medicine Name: Manjisthadi kwath, Reference: Sahasrayogam , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1)Pidika on face with any one classical symptom of Mukhadushika
2)Patients between age group 18-30 years of either sex. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1)Pregnant and Lactation
2)Patient with symptoms of acne rosacea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Know the Efficacy of Vatapatradi Lepa and Lodhradi Lepa with Manjisthadi Kwath with Special Reference to Acne Vulgaris |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aims and objectives:
1)To compare the efficacy of Vatapatradi and Lodhradi lepa with Manjisthadi kwath in the management of Mukhadushika with special reference to acne vulgaris.
2)To study the efficacy of Vatapatradi Lepa with Manjisthadi kwath in the management of Mukhadushika with special reference to acne vulgaris.
3) To study the efficacy of Lodhradi lepa with Manjisthadi kwath in the management of Mukhadushika
with special reference to acne vulgaris. |
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 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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 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
|
Mukhadushika is explained under kshudrarogas.It is characterized by shalmali kantak sadrush pidika on face due to vitiation of kapha , vata , rakta dhatu. It corelates to acne vulgaris explained in modern science.Acne is estimated to affect 9.4% of the global population making it 8th most prevalant disease worldwide.Peak severity is seen in late teenage years but acne may persists into 3rd decade and beyound. Acne vulgaris is a follicular disorder affecting susceptible pilosebaceous follicles.The condition commonly manifest with papules,pustules and nodules.Pathologic events originates in the sebaceous follicle that are predominantly found on the face ,neck and upper trunk.In pathogenesis of acne many different factors play a role altered abnormal status with increased androgens in men and increased androgen properties of progesteron and other hormones in women.Follicular keratization : Hyperkeratotic plugs form in follicle opening. Hyperplasia of sebaceous gland with increased sebum production secondary to hormonal changes.Colonization of follicle by proprionibacterium acnes,which produce lipases splitting free fatty acids and releasing inflammatory mediators. Treatment needs to be continued for at least 6 weeks to produce effect.The treatment of acne vulgaris may consists of topical therapy ,systemic therapy or combination of both.Topical therapy alone is indicated for mild to moderate lesions.Benzoyl peroxide 5% gel ,topical antibiotics erythromycin,clindamycin are used.In moderately severe cases systemic therapy is given which includes only estrogens ,retinoids ,antibiotics.Using antibiotics for acne treatment for prolonged period results in antibiotic resistance and can have a significant negative impact on gastrointestinal microbiome. Face is the most important for reflecting the beauty of person which is affected in mukhadushika.Ayurveda relatively proved to be efficacous in treatment of skin disease.Acharyas mentioned various therapeutic procedures like Jalaukavacharana , vaman,siravedha,pralepa,abhyanga.In vatapatradi lepa vata is kashaya and sheeta virya . Malati is kapha pitta shamak.Raktachandan is raktashamak. Kushtha is tridosha shamak.Kaleeyaka is tikta,ruksha,ushna virya.In lodhradi lepa lodhra is kashaya,kaphaghna and sheeta virya. Dhanyaka is kashaya,tikta,madhur vipaka.Vacha is kashaya and ushna virya.In manjisthadi kwath manjistha is madhur ,kashaya alleviates kapha and used in rakta vikaras and ushna virya. Hence present study is aimed to evaluate and compare the efficacy of vatapatradi lepa and lodhradi lepa with manjisthadi kwath in mukhadushika with spoecial reference to acne vulgaris. |