| CTRI Number |
CTRI/2025/02/080037 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [lepa chikitsa] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the Effectiveness of Siddharthakadi Lepa in the management of Mukhadushika w.s.r. to Acne Vulgaris in Adults. |
|
Scientific Title of Study
|
A Randomized Clinical trial to study the Effectiveness of Siddharthakadi Lepa in the management of Mukhadushika w.s.r. to Acne Vulgaris in Adults |
| 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 Nikita Gajanan Pande |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No. 18, Swasthvritta and Yoga Department,Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar,Amravati
Amravati.
Amravati
MAHARASHTRA
444605
India |
| Phone |
9420244300 |
| Fax |
|
| Email |
pandenikita99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay K Chopkar |
| Designation |
Guid and HOD Department of Swasthavritta and Yoga |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No 18, Swasthavritta and Yoga department,Vidarbha Ayurved Mahavidyalaya and hospital,Dhanvantari Nagar,Amravati
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9423105104 |
| Fax |
|
| Email |
skchopkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Gajanan Pande |
| Designation |
PG Scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
OPD No 18, Swasthavritta and Yoga department,Vidarbha Ayurved Mahavidyalaya and hospital,Dhanvantari Nagar,Amravati
Amravati
Amravati
MAHARASHTRA
444605
India |
| Phone |
9420244300 |
| Fax |
|
| Email |
pandenikita99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurved Mahavidyalaya and Hospital, Dhanvantari Nagar, Chatri Talao Road Amravati. Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
| Address |
Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati. |
| 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 Nikita Gajanan Pande |
Vidarbha Ayurved Mahavidyalaya,Amravati |
OPD No.18 Swasthavritta and Yoga department, Vidarbha Ayurved Mahavidyalaya and Hospital,Dhanvantari Nagar, Amravati, Amravati,
Amravati
MAHARASHTRA |
9420244300
pandenikita99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M.Vidarbha Ayurved Mahavidyalaya,Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVAN, (2) 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 | Procedure | - | Lepa chikitsa | (Procedure Reference: Yog Ratnakar, Procedure details: Siddharthakadi Lepa (5gm) was applied on the face opposite to the direction of orientation of hairs. 1/2 angula i.e. 10mm thick i.e. 1cm as local application in the morning for 10-15 mins for a duration of 60 days as per guidelines mentioned in Sharangdhar Samhita uttarkhanda, Bhavaprakasha madhyam khanda, Ashtang Hridayam, Sushruta Samhita, contents of lepa was taken in equal quantity and mix it with normal water.)
(1) Medicine Name: Siddharthakadi lepa, Reference: Yog Ratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 2 Months | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar Samhita Uttarakhand , Procedure details: Lepa procedure- 1. The body portion of lepa should be clean. 2. The lodhra, vacha, sarshap, saindhav mix it all in equal quantity. 3. In application on the same mixture on the face should be done. 4. It should be kept for 10-15 minutes or till lepan to be dry. 5.It should be clean with wet cotton with warm water)
(1) Medicine Name: Siddharthakadi lepa, Reference: Bhav Prakash Madhyam Khanda 61/35, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject having age group 18-30 years, irrespective of their gender, marital status, economic status & religion.
2. Subject with 2 or more than 2 classical signs & symptoms of Mukhadushika i.e. shalmali kantakvat Pidika, ruja, number of pidaka, kandu, mukhavaivarnya.
3. Subject ready to give written informed consent.
4. Subject who are physically and mentally healthy.
5. Subject having grade 1,2 & 3 acne.
|
|
| ExclusionCriteria |
| Details |
1. Grade 4 Acne.
2. Patient also taking another treatment for acne.
3. Subject with age group below 18 years and 30 years of age of both sexes.
4. Subject having history of any other general systemic illness or systemic disorders like TB, HIV or other skin diseases like eczema, scabies, another skin disorders at the diseased site.
5. Subject with pidakas of kushta (leprosy).
6. History of Hypothyroidism and PCOD.
7. Pregnant ladies.
|
|
|
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 |
Complete remission from Acne vulgaris
Marked improvement in Acne
vulgaris
Mild improvement in Acne vulgaris
|
0th day
7th day
15th day
30th day
45th day
60th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Remission from all kind of Acne vulgaris
Clear skin achieved |
30th day
45th day
60th day
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/02/2025 |
| 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="8"
Days="0" |
|
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)
|
A randomized clinical trial will be conducted to study the effectiveness of Siddharthakadi lepa in Mukhadushika with special reference to Acne vulgaris.
Trial will be conducted in our institute and its periphery. Total 80 patients diagnosed with Acne vulgaris by The investigators Global Assessment Scale will be selected.
Patients will advised to apply Siddharthakadi lepa. The study will be done in 60 days.
Result will be derived, Data analysis will be done by using appropriate Statistical test.
Primary outcomes will to be study the effectiveness of Siddharthakadi lepa in Acne vulgaris and complete, moderate and mild remission of Acne vulgaris in patients. |