| CTRI Number |
CTRI/2025/07/090490 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study on the management of Acne Vulgaris |
|
Scientific Title of Study
|
A Clinical Study on the Efficacy of Khadira Kwatha Oral and Lodhradi Lepa External in the Management of Mukhadushika |
| 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 Chevikula Sai Deepika |
| Designation |
Post Graduate in Kayachikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic Medical College and Hospital |
| Address |
Dr BRKR Government Ayurvedic Medical College and Hospital
Department of Kayachikitsa
Division 2
Room 2
Erragadda
Hyderabad
Pincode:500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8247838279 |
| Fax |
|
| Email |
saideepika086@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kairica Laxmikantham |
| Designation |
Professor MD Ayurveda Department of Kayachikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic Medical College and Hospital |
| Address |
Dr BRKR Government Ayurvedic Medical College and Hospital
Department of Kayachikitsa
Division 2
Room 2
Erragadda
Hyderabad
Pincode:500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kairica Laxmikantham |
| Designation |
Professor MD Ayurveda Department of Kayachikitsa |
| Affiliation |
Dr BRKR Government Ayurvedic Medical College and Hospital |
| Address |
Dr BRKR Government Ayurvedic Medical College and Hospital
Department of Kayachikitsa
Division 2
Room 2
Erragadda
Hyderabad
Pincode:500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9989398463 |
| Fax |
|
| Email |
drlaxmikantham20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BRKR Government Ayurvedic Medical College and Hospital Erragadda
Hyderabad
Pincode 500038 |
|
|
Primary Sponsor
|
| Name |
Dr Chevikula Sai Deepika |
| Address |
Dr BRKR Government Ayurvedic Medical College and Hospital Erragadda
Hyderabad
Pincode 500038 |
| Type of Sponsor |
Other [Self] |
|
|
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 Chevikula Sai Deepika |
Dr BRKR Government Ayurvedic Medical College and Hospital |
Dr BRKR Government Ayurvedic Medical College and Hospital
Department of Kayachikitsa
Division 2
Room number 2
Erragadda
Hyderabad
500038
Hyderabad
TELANGANA |
8247838279
saideepika086@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Dr BRKR Government Ayurvedic Medical College and Hospital |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KHADIRA KWATHA, Reference: CHAKRADATTA KUSHTA ROGA ADHIKARA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: LODHRADI LEPA, Reference: CHAKRADATTA KSHUDRA ROGA ADHIKARA, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as Mukhadushika on the basis of lakshanas like Ruja Ghana Sparsha Medo garbha Shalmali kantaka aakara pidaka
Patients will be selected irrespective of gender religion occupation and socioeconomic status
Patients who are willing to participate in the study and who sign the consent form |
|
| ExclusionCriteria |
| Details |
Patients age below 18 years and above 35 years of either gender
Patients having pidaka other than the face
Patients suffering from any other skin diseases like vitiligo eczema psoriasis
Patients with uncontrolled diabetes mellitus uncontrolled hypertension tuberculosis malignancy and other systemic disorders which interferes with the course of treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the Size and discharge of Acne |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the symptoms of Acne Vulgaris |
30 Days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/07/2025 |
| 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="6"
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 a disease mentioned under Kshudra roga in Ayurveda Samhitas. Acharya Sushruta was the first person to describe Mukhadushika. Sushruta has described as this disease as the eruptions resembling the Shalmali kantaka (thorns of shalmali tree) which occurs on the face of youth due to vitiation of Vata and Kapha doshas and dushti of Rakta. Mukhadushika is characterized by Ruja (pain), Ghana Sparsha (hard to touch), Medogarbha (filled with sebum), Shalmali kantaka aakara pidaka (shape like shalmali thorn). Mukhadushika may be correlated with Acne Vulgaris as there is resemblance with lakshanas mentioned in Ayurveda Samhitas. Acne is chronic inflammation of the pilosebaceous units. it is characterized by papules, pustules, nodules, seborrhoea (oily skin) and possibly scarring. Acne is most common in teenagers and young adults, generally starts during puberty and has been estimated to affect over 90% of adolescents particularly in females. |