CTRI Number |
CTRI/2025/06/089022 [Registered on: 18/06/2025] Trial Registered Prospectively |
Last Modified On: |
17/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
ROLE OF VATAPATRADI LEPA IN THE MANAGEMENT OF MUKHADUSHIKA w.s.r TO ACNE VULGARIS" |
Scientific Title of Study
|
A RANDOMISED OPEN-LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF VATAPATRADI LEPA IN THE MANAGEMENT OF MUKHADUSHIKA w.s.r ACNE VULGARIS |
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 Shivani Mishra |
Designation |
Pg Scholar |
Affiliation |
Jammu Institute of Ayurveda and Research Nardani Kot Balwal Road Jammu |
Address |
Dept. of PG Studies in Kayachikitsa Jammu Institute of Ayurveda and Research,Kot Bhalwal road Nardani Jammu and Kashmir
Jammu Institute of Ayurveda And Research
Jammu
JAMMU & KASHMIR
181123
India
Jammu JAMMU & KASHMIR 181123 India |
Phone |
6006912792 |
Fax |
|
Email |
shivanimishra5474@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nitin Mahajan |
Designation |
Principal |
Affiliation |
Jammu Institute of Ayurveda and Research |
Address |
Dept. of PG Studies in Kayachikitsa Jammu Institue of Ayurveda and Research, Kot Bhalwal road Nardani Jammu and Kashmir
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH
Jammu
JAMMU & KASHMIR
181123
India
Jammu JAMMU & KASHMIR 181123 India |
Phone |
9419119123 |
Fax |
|
Email |
drnitinmahajan1608@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nitin Mahajan |
Designation |
Principal |
Affiliation |
Jammu Institute of Ayurveda and Research |
Address |
Dept. of PG Studies in Kayachikitsa Jammu Institue of Ayurveda and Research, Kot Bhalwal road Nardani Jammu and Kashmir
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH
Jammu
JAMMU & KASHMIR
181123
India
Jammu JAMMU & KASHMIR 181123 India |
Phone |
9419119123 |
Fax |
|
Email |
drnitinmahajan1608@gmail.com |
|
Source of Monetary or Material Support
|
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH NARDANI JAMMU 181123 INDIA |
|
Primary Sponsor
|
Name |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH |
Address |
Kot Balwal, Nardani ,Jammu, Jammu & Kashmir |
Type of Sponsor |
Research institution and hospital |
|
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 Shivani Mishra |
JAMMU INSTITUTE OF AYURVEDA AND RESERACH |
Room no. 102 First Floor Department pf Kayachikitsa Jammu
JAMMU & KASHMIR Jammu JAMMU & KASHMIR |
6006912792
shivanimishra5474@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: (1) M, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PIDAKA, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vatapatradi Lepa, Reference: Sharangdhara samhita, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shalmaliadi Lepa, Reference: Sharangdhara samhita, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
30.00 Year(s) |
Gender |
Both |
Details |
1. Patients of age 16-30 yrs. will be taken for study.
2. Patients representing signs and symptoms of Mukhadushika who will be willing to participate in study .
3. Subjects of both genders will be considered. |
|
ExclusionCriteria |
Details |
1. Patients with severe nodular acne.
2. Pregnancy and nursing women.
3. Acne caused by the dandruff will be excluded.
4. Patient having any systemic pathology.
5. Clinically infected lesion that require. treatment with systemic antibiotics and or local antiseptic and or other treatment.
6. Patient on any other anti acne therapy |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
SUBJECTIVE CRITERIA:
1.Number of Pidika
2.Area occupied by Pidika
3.kandu
4.Daha
5.Paka
6.Srava
7.Vedana |
Baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
Number of Pidika
Area occupied by Pidika |
Baseline 15th day,30th day,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)
|
01/07/2025 |
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 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
|
Mukhadushika’ is one of such diseases illustrated in Ayurveda which affects the beauty of the face. This diseases has
been described under Kshudraroga in
the classical text. Acharaya Shusruta
first described Mukhadushika in Kshudraroga in Nidaansthan 13 /38 in Chikitsasthana 20/37 .It occurs due to
vitiation of kapha Dosha, Vata Dosha and Rakta Dhatu.
In Mukhadushika the eruption like Shalmali
Kantaka.The common site of Mukhadushika
is face, in which forehead,cheeks,nose, and chin are the prominent sites .
It can be
coorelated with Acne Vulgaris in modern science . Acne Vulgaris is an
incredibly common cutaneous inflammatory skin disorder in developed nation as well as in developing countries like
India . In this condition many teenagers, characterized by blockage
of pilosebaceous duct and involves area
of skin where sebaceous glands are most numerous and active .However , with the rise in
hormones, food sensitivities, digestive problems, toxic environments, stress,
high carbohydrate diets, and mineral and vitamins deficiencies, acne plagues
all ages .
Topical Antibiotic therapy is recommended for
its treatment but their chemical compounds creates adverse effects on the body,
so natural non toxic medicines should be used to bring the skin into normal state
by treating problem like Mukhadushika .
Acne Vulgaris develops as a result of hypersensitivity
of the sebaceous glands to normal levels of circulating androgens. This process
is further exacerbated by the presence of Cutibacterium acnes [ C acnes ] In Mukhadushika Saruja (painfull), Pidika
(eruption) are hallmarks of Mukhadushika .
Vitiated Dosha get accumulated and
obstruct the Lomarupa (pilosebaceous
unit) causing local
swelling and micro comedone formation .Paka
(inflammation) of these elements leads to papules,pustules, and cyst formation
which on rupture cause Vranavastu (scar) formation. Allopathic
treatments includes the use of topical retinoids, benzoyl peroxide , oral
antibiotics, steroids , and oral
isotretinoin . Although its use is limited by teratogenicity and
other side effects. Ayurveda has a
great potential in the management of Acne vulgaris is reported. Two types of Chikitsa are explained in the management
of Mukhadushika i.e, Shodhana and Shamanachikitsa. Shodhanachikitsa
includes Vaman ,Virechana, Nasya, Jalaukavcharna and Shiravyadha. Shaman Chikitsa
includes various type of lepa and
oral medication.
In
present study one such formulations of lepa
which is given in Sharangdharasamhitauttarkhand
11 /14-15 is Vatapatradi lepa(
trial drug ) is taken to assess its efficacy on Mukhadushika w.s.r to Acne vulagaris and compared with Shalmaliadi lepa ( controlled). ·
The word ‘Mukha’ means face or countenance and Dushika means face spoiler or eruption that configures
the Mukh a(face) .
·
The word Mukhadushika is derived from Mukhamdushayathi Vivarnamkarothi
iti Mukhadushika means that which disfigures the Mukha along with causing discolouarion.
|