| CTRI Number |
CTRI/2025/03/082131 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Lodhra-Vacha-Dhanyak Gel in Treating Facial Acne in Individuals Aged 12-30 Years |
|
Scientific Title of Study
|
Evaluation Of Effectiveness Of Lodhra-Vacha-Dhanyak Gel As Topical Application In Yuvan-Pidika (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 |
Geetanjali Kanungo |
| Designation |
Post Graduate Scholar |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute |
| Address |
OPD No.8,Department of Swasthavritta and Yoga
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute
Science Hills, Nehru Nagar- Kolar Bypass Road , Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9039449596 |
| Fax |
|
| Email |
geetanjalikanungo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Marwaha |
| Designation |
Professor |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute |
| Address |
OPD No.8,Department of Swasthavritta and Yoga
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute
Science Hills, Nehru Nagar- Kolar Bypass Road , Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425377177 |
| Fax |
|
| Email |
marwahaayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Marwaha |
| Designation |
Professor |
| Affiliation |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute |
| Address |
OPD No.8,Department of Swasthavritta and Yoga
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute
Science Hills, Nehru Nagar- Kolar Bypass Road , Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425377177 |
| Fax |
|
| Email |
marwahaayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute
Science Hills, Nehru Nagar- Kolar Bypass Road , Bhopal
462003 (M.P.), India |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute , Bhopal |
| Address |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute
Science Hills, Nehru Nagar- Kolar Bypass Road , Bhopal
462003 (M.P.), India
|
| Type of Sponsor |
Government 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 Geetanjali Kanungo |
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute, Bhopal |
OPD No.8,Department of Swasthavritta and Yoga
Science Hills, Nehru Nagar- Kolar Bypass Road , 462003
Bhopal
MADHYA PRADESH |
9039449596
geetanjalikanungo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute, Institutional Ethics Committee |
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 (Non Ayurveda) | | - | Water Based Gel | Water-Based Gel evenly to the entire facial area twice daily for 45 consecutive days after washing
the face. | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Susruta Sutra Sthan 18/6, Procedure details: Twice per day after washing the face)
(1) Medicine Name: Lodhra - Vacha -Dhanyak Lepa , Reference: Ashtang Hriday , Uttarsthan chapter 32/ 3, Route: Topical, Dosage Form: Not Applicable, Dose: 5(g), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Unmarried subjects of 12-30 yrs of the age group of either sex, irrespective of their
religion, caste, or race will be included.
2.Subjects affected by Acne Vulgaris exclusively on their facial region.
3.Subjects willing to sign the informed consent form and are ready to stop any other
specific acne treatment. |
|
| ExclusionCriteria |
| Details |
1.Subjects with acne vulgaris affecting areas other than the face, such as the chest
and back.
2.Subjects with any other dermatological condition.
3.Subjects who are exposed to sunlight for extended periods.
4.Known cases of hormonal disorders or undergoing steroid therapy or hormone
replacement therapy.
5.The subject presents with cysts, abscesses, and widespread scarring across the
face.
6.Known cases of serious systemic diseases. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
After the study, we anticipate being able to showcase the effectiveness of
Lodhra-Vacha-Dhanyak gel in the treatment of Yuvan-Pidika (Acne Vulgaris). This
treatment approach could offer a safe, natural, readily accessible, and cost-effective
management option. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acne Vulgaris is a chronic inflammatory skin condition that primarily affects young individuals, with an estimated 85% of those aged 12-25 experiencing it, as reported by the Global Burden of Disease Study 2019. The condition is driven by the bacteria Propionibacterium acne and Staphylococcus epidermidis and presents with both non-inflammatory and inflammatory lesions, including comedones, papules, nodules, and cysts.In Ayurveda, Acharya Sushruta first described this condition as Yuvan-Pidika under the classification "Kshudraroga," noting its connection to the vitiation of Kapha, Vata, and Rakta, which leads to eruptions resembling Shalmali kantak. This understanding aligns closely with the symptoms of Acne Vulgaris. Ayurvedic remedies for Yuvan-Pidika, such as a paste made from Lodhra (Symplocos racemosa), Vacha (Acorus calamus), and Dhanyak (Coriandrum sativum), have been documented by various scholars as effective treatment. This study is a single-blind, randomized controlled clinical trial aimed at evaluating the effectiveness of Lodhra-Vacha-Dhanyak gel in treating Yuvan-Pidika (Acne Vulgaris). A total of 60 patients, aged 12-30yrs, will be randomly selected using a simple random sampling technique and divided into two groups of 30. - Group A (Trial Group) will apply Lodhra-Vacha-Dhanyak gel evenly to the entire facial area twice daily for 45 consecutive days after washing their face.
- Group B (Placebo Control Group) will apply a water-based gel in the same manner for the same duration.
The diagnosis of Yuvan-Pidika will be based on the presence of facial eruptions (Pidika). The study will take place at Pt. Khushilal Sharma Govt. Ayurveda College & Hospital, Bhopal (M.P.). The goal is to demonstrate that Lodhra-Vacha-Dhanyak gel can provide a safe, natural, accessible, and cost-effective treatment option for Acne Vulgaris. |