| CTRI Number |
CTRI/2024/12/078302 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparative Study of Lodhradi Lepa and Majuphaladi Lepa for Treating Acne Vulgaris (Mukhadushika) |
|
Scientific Title of Study
|
Comparative clinical study of lodhradi lepa and Majuphaladi lepa in Mukhadushila with special reference to 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 Triveni Yashwant Wanole |
| Designation |
Pg scholer Kaychikista |
| Affiliation |
Shree Saptashrungi Ayurved Medical College and Hospital |
| Address |
Shree Saptashrungi Ayurved Medical College and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003
Shree Saptashrungi Ayurved Medical College and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003
Nashik
MAHARASHTRA
420003
India |
| Phone |
9730244462 |
| Fax |
|
| Email |
triveniwanole7797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Sachin Patil |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Medical College and Hospital |
| Address |
OPD no 2 department of kaychikista Shree Saptashrungi Ayurved Mahavidyalau and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003
OPD no 2 department of kaychikista Shree Saptashrungi Ayurved Mahavidyalay and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003
MAHARASHTRA
420003
India |
| Phone |
9730244462 |
| Fax |
|
| Email |
drkavitasp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Triveni Yashwant Wanole |
| Designation |
Pg scholer Kaychikista |
| Affiliation |
Shree Saptashrungi Ayurved Medical College and Hospital |
| Address |
OPD no 2 department of kaychikista Shree Saptashrungi Ayurved Medical College and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003 Maharashtra
OPD no 2 department of kaychikista Shree Saptashrungi Ayurved Medical College and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003 Maharashtra
MAHARASHTRA
420003
India |
| Phone |
9730244462 |
| Fax |
|
| Email |
triveniwanole7797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchavati Panchavati Nashik 422003 Maharashtra india |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyala Kamal Nagar Hirawadi Panchavati Nashik |
| Address |
Department of kaychikista Shree Saptashrungi Ayurved Mahavidyala Kamal Nagar Hirawadi Panchavati Nashik Maharashtra 420003 |
| Type of Sponsor |
Private 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 Triveni Yashwant Wanole |
Shree Saptashrungi Ayurved Mahavidyala and Hospital Kamal Nagar Hirawadi Panchavati Nashik |
OPD no 2 department of kaychikista Shree Saptashrungi Ayurved ayurved College and Hospital Kamal Nagar Hirawadi Panchavati Nashik 420003 Maharashtra
Nashik
MAHARASHTRA |
9730244462
triveniwanole7797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyala Kamal Nagar Hirawadi Panchavati Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushrut samhita , Procedure details: Not applicable )
(1) Medicine Name: Majuphaladi lepa , Reference: Bharat bhaishjya ratnakar makradi adhyay kalpa kramak 5377, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushrut samhita , Procedure details: Not applicable )
(1) Medicine Name: Lodhradi lepa , Reference: Bharat bhaishjya ratnakar 4/15, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient having lesion with pain burning and type of lesion pn the face
2 The diagnosed patient of Mukhadushika according to classical signs and symptoms saruja daha and Kandu
3 Patient in the age group of 18to 40 years
4 Patient will be selected irrespective of sex religion socioeconomic status etc |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduc symptoms such as saruja daha kandu on 0 day and 15th day that is 2 weeks after application of lepa |
0th 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce symptoms such as saruja daha kandu on 5th & 10th day that is one week after application of lepa no other comorbidities seen in secondary outcome |
5th day 10th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2024 |
| 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
|
In authentic ayurveda texts there is a groupof disease called kshudra roga which include 44 diseases Mukhadushika is explained by sushruta aacharya It is characterised by shalmali kantak sadrusha pidika on face It is caused by vitiated kapha vata dosha and rakta dhatu together which makes face ugly and also known as yuvan pidika Objective Primary objective To compare the efficacy of lodhradi lepa and majuphaladi lepa in mukhdushika with special reference to acne vulgaris Secondary objective To study about Mukhadushika in detail To study about acne vulgaris in detail To study the properties of Lodhradi lepa To study the properties of majuphaladi lepa Participant 60 adult diagnosed with mukhdushika meeting inclusion and exclusion criteria from OPD and IPD of department of kaychikista of shree Saptashrungi Medical College and Hospital Nashik Intervention 30 pt of lodhradi lepa - Lodhradi lepa local application on face in morning 30 pt of majuphaladi lepa - Majuphaladi lepa local application on face in morning Procedure of application
Primary outcome Reduce the sign and symptoms of Mukhdushika Secondary outcome No Recurrency of mukhdushika Treatment duration - 15 days Follow up 0 5th 10th 15th Data analysis Data will be analysed using appropriate statistical methods to compare the effectiveness of intervention on the primary and secondary outcome Ethical consideration The study will be conducted in accordance with ethical guidelines and with informed consent from participants
|