| CTRI Number |
CTRI/2026/03/105274 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Lodhradi Serum and Lodhradi Paste for treating Pimples |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL TO ASSESS THE EFFICACY OF LODHRADI SERUM AND LODHRADI LEPA IN YUVANPIDIKA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RENU KUMARI YOGI |
| Designation |
MD SCHOLER |
| Affiliation |
National Institute Of Ayurveda |
| Address |
KRIYA SHARIR DEPARTMENT
NATIONAL INSTITUTE OF AYURVEDA JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
07976761047 |
| Fax |
|
| Email |
yogirenu97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Chhaju Ram Yadav |
| Designation |
Dean (PhD) and HOD |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
ROOM NO 237 KRIYA SHARIR DEPARTMENT
NATIONAL INSTITUTE OF AYURVEDAJAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Chhaju Ram Yadav |
| Designation |
Dean (PhD) and HOD |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
ROOM NO 237 KRIYA SHARIR DEPARTMENT
NATIONAL INSTITUTE OF AYURVEDAJAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
9460866101 |
| Fax |
|
| Email |
dr.yadavcr@gmail.com |
|
|
Source of Monetary or Material Support
|
| national institute of ayurveda jorawar singh gate amer road rajasthan india 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jorawar Singh Gate Amer Road Rajasthan India |
| Address |
NATIONAL INSTITUTE OF AYURVEDA JORAVAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN INDIA 302002 |
| 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 RENU KUMARI YOGI |
National Institute of Ayurveda Hospital ,Jaipur. |
OPD NO 3 SKIN DISEASE TREATMENT UNIT KRIYA SHARIR DEPARTMENT NATIONAL INSTITUTE OF AYURVEDA JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN INDIA 302002
Jaipur
RAJASTHAN |
07976761047
yogirenu97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: LODHRADI LEPA, Reference: BHAISAJYA RATNAVALI, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -NO | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishtha Ghan Vati, Reference: CHARAK SAMHITA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LODHARADI SERUM, Reference: NA, Route: Topical, Dosage Form: Sattva, Dose: 5(drops), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -NO |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with classical signs and symptoms(such as Shalmali Kantakprakhya,saruja,Ghana,Medogarbha) of Yuvanpidika
Subjects ready to give informed written consent for the trial
|
|
| ExclusionCriteria |
| Details |
Known case of any acute/chronic skin diseases.
Known cases of Systemic diseases or Metabolic disorders
Subjects taking medication for any physical or psychological condition
Pregnant or lactating women
Regular smokers or alcohol users
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in GAGS score in patients of Yuvanpidika |
Change in GAGS score in patients of Yuvanpidika After 60 days from the base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of difference in efficacy of Lodhradi Serum and Lodhradi Lepa on subjective parameters in patients of Yuvanpidika |
2 MONTHS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/04/2026 |
| 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 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
|
This study is a comparative, prospective, interventional Phase II clinical trial designed to evaluate and compare the efficacy of Lodhradi Serum and Lodhradi Lepa along with Manjistha Ghan Vati in the management of Yuvanpidika (acne vulgaris)
Yuvanpidika is described in classical Ayurvedic texts such as Sushruta Samhita and Charaka Samhita as a Kapha-Vata-Rakta predominant disorder characterized by Shalmali-kantaka-like eruptions, pain (Saruja), hardness (Ghana), and Medogarbha (sebaceous content). Manjistha is mentioned under Varnya Mahakashaya in Charaka Samhita and is selected for its Raktashodhaka and Varnya properties
A total of 60 patients (18–40 years) diagnosed with Yuvanpidika will be randomly divided into two groups: Group A: Lodhradi Serum (local application once daily) + Manjistha Ghan Vati 500 mg twice daily Group B: Lodhradi Lepa (½ Angula thickness, once daily) + Manjistha Ghan Vati 500 mg twice daily
The duration of treatment will be 60 days, with follow-up assessments every 15 days
Primary OutcomeAssessment of difference in efficacy between the two groups using the Global Acne Grading System (GAGS) score.Secondary OutcomesAssessment based on subjective parameters includingPidika (eruption)Kandu (itching)Ruja (pain)Daha (burning sensation)Shrava (discharge)Snigdhata (oiliness)Vaivarnya (scarring)
Statistical analysis will include descriptive statistics and inferential tests such as the Wilcoxon signed-rank test and Mann–Whitney U test
The study will be conducted at the National Institute of Ayurveda, Jaipur, after obtaining ethical approval and registration with the Clinical Trial Registry of India (CTRI).
The aim of the study is to determine whether the novel dosage form (Lodhradi Serum) offers superior therapeutic efficacy compared to the classical Lodhradi Lepa in the management of Yuvanpidika |