| CTRI Number |
CTRI/2024/12/077889 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect oF Kushta and Arjuna in Yuvanapidaka (Acne Vulgaris) |
|
Scientific Title of Study
|
A Pharmacognostical and clinical study of kushta (Saussurea lappa C.B. Clarke) And Arjuna ( Terminalia arjuna Roxb. Wight and Arn.) In Yuvanapidaka w.s.r 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 Nikita Meghwal |
| Designation |
PG Scholar of Dravya Guna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College, Rada ji circle Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8949351522 |
| Fax |
|
| Email |
meghwalnikita123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Chandra Mishra |
| Designation |
Associate Professor of Dravya Guna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Rada ji Circle Ambamata Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9460012476 |
| Fax |
|
| Email |
m.raj3011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Meghwal |
| Designation |
PG Scholar of Dravya Guna Vigyan Vibhag |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Rada ji Circle Ambamata Udaipur 313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
8949351522 |
| Fax |
|
| Email |
meghwalnikita123@gmail.com |
|
|
Source of Monetary or Material Support
|
| From M.M.M. College Pharmacy. If not available from M.M.M College Pharmacy then Drug will be collected from field after proper identification |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Madan Mohan Malviya Government Ayurved College Rada Ji Circle Ambamata Udipur 313001 Rajasthan |
| 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 Nikita Meghwal |
Attached Hospitals of Madan Mohan Malviya Government Ayurved College Udaipur 313001 Rajsthan |
Attached Hospitals of Madan Mohan Malviya Government Ayurved College Department of Swasthavritta Opd No.24 Udaipur 313001 Rajsthan.
Udaipur
RAJASTHAN |
08949351522
meghwalnikita123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malaviya Government Ayurved College Udaipu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (2) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), (3) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjuna bark fine powder, Reference: yoga ratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: Additional Arjuna bark fine powder for external application. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushta root fine powder, Reference: Sushrutha samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -Additional Kushta root fine powder for external application | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mix fine powder of Kushta root and Arjuna bark , Reference: Sushrutha samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -Additional fine powder of both drug Kushta root and Arjuna bark for external application |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age of patients between 16 to 30 years irrespective of gender and socio-economic status.
Patient with cardinal features of Yuvanapidaka.
Who have give consent for undergoing the current clinical study will include.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from any major systemic disorders and infectious acne.
Patients having inflammatory cysts, nodules and other skin disorders or drug dependency.
Pregnant women and lactating mother.
Patient not willing to sign the consent form.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Objective parameters { HB %, CBC,ESR }and Subjective parameters |
60 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Subjective parameters |
15 Days ,30 Days, 45 Days,60 Days |
|
|
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)
|
25/12/2024 |
| 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="0"
Months="10"
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
|
This Study is About A Pharmacognostical and Clinical Study of Kushta { Saussurea lappa C.B.Clarke } and Arjuna { Termanalia arjuna Roxb. Wight and Arn.} In Yuvanapidaka w.s.r. to Acne Vulgaris . There will be 3 Groups in the Study.In Group A - Arjuna Bark fine powder = 2 Capsule each 500mg { at one time } = TDS { Three times a day } = 3 gm per day will be given. and Fine powder for Local application three time in a week .
In Group B - Kushta root fine powder = 1 Capsule each 500mg { at one time } = TDS { Three times a day } = 1.5 gm per day will be given.and Fine powder for Local application three time in a week .
In Group C - Mixing powder of Both Kushta root and Arjuna bark = 2 Capsule each 500mg { at one time } = TDS { Three times a day } = 3 gm per day will be given. and Fine powder for Local application three time in a week .
Trial will be Conduct for a period of 2 months { 60 days } Follow up of the case will be after every 15 days that is 4 time { At 15 days ,At 30 days , At 45 days , At 60 days } during treatment . Final assessment will be done after
completion of 2 months of treatment course on the basis of subjective , objective assessment and laboratory investigation.
The data will be analyzed scientifically and statistically. |