| CTRI Number |
CTRI/2025/08/093389 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Lodhradi lepa and Manjishthadi tail nasya with Lodhradi lepa in treatment of Acne vulgaris |
|
Scientific Title of Study
|
Randomised clinical trial to compare the efficacy of Lodhradi lepa and
Manjishthadi taila Marsha nasya with Lodhradi lepa in Mukhadushika in perspective of 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 Priya Bangar |
| Designation |
PhD scholar |
| Affiliation |
Center for Post Graduate Studies and Research in Ayurved, Tilak Ayurved College |
| Address |
Panchakarma Department,Tilak Ayurved college, 583/2 Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
9881727311 |
| Fax |
|
| Email |
drpriyabangar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Huparikar |
| Designation |
HOD Professor |
| Affiliation |
Center for Post Graduate Studies and Research in Ayurved ,Tilak Ayurved College, |
| Address |
Panchakarma Department, Tilak Ayurved college, 583/2 Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9823050402 |
| Fax |
|
| Email |
ayurvedapune@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Bangar |
| Designation |
PhD Scholar |
| Affiliation |
Center for Post Graduate Studies and Research in Ayurved, Tilak Ayurved College |
| Address |
Panchakarma Department, Tilak Ayurved college, 583/2 Rasta peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9881727311 |
| Fax |
|
| Email |
drpriyabangar@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research institute and attached hospital ARSMH, Sector No. 25, Nigdi, Pune, Maharashtra, India, Pin code- 411044
|
| RSMs CPGSRA,Tilak Ayurved college and attached Tarachand hospital, 583/2 Rasta Peth, Pune, Maharashtra, 411011 |
|
|
Primary Sponsor
|
| Name |
Dr Priya Bangar |
| Address |
RSMs CPGSRA,Tilak Ayurved college, 583/2 Rasta Peth Pune, Maharashtra, 411011 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya Bangar |
Seth Tarachand Ramnath hospital |
Department of Panchakarma, Seth Tarachand Ramnath hospital,Survey No 508/2 vidya Nanal
shashtri street Rasta Peth
Pune 11
Pune
MAHARASHTRA |
9881727311
drpriyabangar@gmail.com |
| Dr Priya Bangar |
Ayurved rugnalya and Snowbell multispeciality hospital |
Ayurved rugnalya and Snowbell multispeciality hospital, Department of Panchakarma, OPD 216,Sector no
27,Pradhikaran,Nigdi,Pune
411044,
Pune
MAHARASHTRA |
9881727311
drpriyabangar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| P.D.E.A.S college of Ayurved & Research center , Nigdi, Pune - 44 |
Approved |
| Tilak ayurved college, Rasta Peth, Pune -11 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Ashtang hridayam, Procedure details: Lepa apply on face in upward or opposite direction of the hair growth. Apply the lepa for specific period i.e. till it starts getting dry, then the applied Lepa will be removed.
)
| | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hridayam , Procedure details: Nasya
procedure will
be conducted
as per SOP
local face and neck
massage with Til tail and swedan
will be
performed.
after that 6
bindu of oil
administration
will be done
for 7 days.)
(1) Medicine Name: Manjishthadi tail, Reference: Yogratnakar, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Participant having Mild to Moderate Acne Vulgaris.
2.Participants will be selected irrespective of sex, religion, occupation with age between 13 to 30 years.
3.Acne affecting the face.
4.Participants Arha for Nasya and lepa karma. |
|
| ExclusionCriteria |
| Details |
1.Drug induced acne i.e. Participants receiving systemic steroids, hormonal therapies, or antibiotics.
2.Participant having acne on other than face.
3.Participant having local wound or infection.
4.Participant having nodular or cystic acne & any other type of acne than Acne vulgaris.
5.Participant suffering from autoimmune disorders like SLE, immunological deficiencies, uncontrolled metabolic disorders like D.M., pregnant & lactating woman. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical features like pain, itching, burning ,number of acne and Global acne grading system scoring scale |
Duration of study–36 months
Duration of treatment: 7 days with follow-up on
8th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effects if any |
Duration of study–36 months
Duration of treatment: 7 days with follow-up on 8th and 15th day |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
07/09/2025 |
| 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="3"
Months="0"
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
|
Acne is estimated to affect 9.4% of the world’s population with the highest prevalence in adolescents. It is a chronic condition affecting more than 85% of adolescents, aged 12-25 years and two-third of adults aged 18 years and older. Acne, often perceived as a mere cosmetic issue, can have profound and lasting emotional and psychological impacts. Many creams, oils, and topical preparations are available for the management of acne, but they only provide temporary effects. However, these have been proven to be less effective. A combination of Manjishthadi oil nasya and Lodhradi lepa would be beneficial for Acne. Nasya treatment can have a long-term and prompt effect on Acne by correcting vitiated doshas, along with local symptoms will be reduced by Lepa treatment. Hence present study is taken to find an effective and safe management for Acne. Primary objective - To compare the efficacy of Lodhradi lepa and Manjishthadi taila Marsha nasya with Lodhradi lepa in the management of Acne. Secondary objective- To observe adverse effects if any. Methodology - 1. Study design - Randomised comparative clinical trial. 2. Study Setting - Location -OPD and IPD Participants of concerned Institutes. Duration of study - 36 months Duration of treatment- 7 days with follow-up on 8th &15th day. 3. Study population - 108 Participants of age group 13-30 years of either gender showing classical sign and symptoms of Acne. Group A - Manjishthadi taila Marsh nasya with Lodhradi lepa for 7 days Group B- Lodhradi lepa for 7 days. Data Analysis - Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervention on the primary and secondary outcomes. Ethical consideration- The study will be conducted with ethical guidelines and with informed consent from participants.
|