| CTRI Number |
CTRI/2022/10/046573 [Registered on: 18/10/2022] Trial Registered Prospectively |
| Last Modified On: |
15/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate The Efficacy Of TVAGROGJIT In The Management Of Acne Vulgaris |
|
Scientific Title of Study
|
Open Labeled Randomized Active Controlled Comparative Clinical Study To Evaluate Effect Of TVAGROGJIT In The Management Of Yauvanpidika With Special Reference To ACNE VULGARIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjiri Keskar |
| Designation |
Professor |
| Affiliation |
Parul Insitute Of Ayurveda |
| Address |
OPD NO 112 Sshalakya Tantra ENT OPD Parul Institute Of Ayurveda Parul Uuniversity Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9822606358 |
| Fax |
|
| Email |
Manjiri.keskar26993@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shailesh Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Insitute Of Ayurveda |
| Address |
OPD NO 116 Kayachikitsa OPD Parul Institute Of Ayurveda Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
shailesh.deshpande260036@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajkumar Rathod |
| Designation |
PG Scholar |
| Affiliation |
Parul Insitute Of Ayurveda |
| Address |
OPD NO 112 SHALAKYA TANTRA ENT OPD Parul Institute Of Ayurveda Parul University Limda Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7600858652 |
| Fax |
|
| Email |
Rathodraj318@gmail.com |
|
|
Source of Monetary or Material Support
|
| Solumiks Herbaceuticals Limited
135 Nanubhai Desai Rd Charmi Road East Khetwadi Girgaon Mumbai Maharashtra 400004 |
|
|
Primary Sponsor
|
| Name |
Dean Faculty Of Ayurveda Parul Institute Of Ayurveda |
| Address |
Parul Institute Of Ayurveda Parul University Limda Vadodara |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Solumiks Herbaceuticals Limited |
135 Nanubhai Desai Rd Charmi Road East Khetwadi GIRGAON MUMBAI Maharashtra 400004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajkumar Rathod |
Parul Ayurveda Hospital Parul University Limda Vadodara |
OPD NO 112 Shalakya Tantra ENT OPD Parul Ayurveda Hospital Limda Vadodara
Vadodara
GUJARAT |
7600858652
Rathodraj318@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: GUDUCHYADI VATI, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Shalmalyadi Lepa Mixed With Milk And Make A Paste To Apply On The Affected Area of Acne Vulgaris As Half Angula Twice In A Day | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: TVAGROGJIT, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Shalmalyadi Lepa Mixed With Milk And Make A Paste To Apply On The Affected Area of Acne Vulgaris As Half Angula Twice In A Day. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient Between 18 To 30 Years Of Age
2)Patients Will Randomly Selected Irrespective Of Their Sex Religion And Occupation Economical And Educational Status
3) The Diagnosis Will Made On The Basis Of Sign And Symptom Of Yauvanpidika As Per Ayurvedic And Modern Text |
|
| ExclusionCriteria |
| Details |
1) Patient Suffering From Any Major Systematic Disorders Like Diabetes Mellitus Hypertension Asthma Tuberculosis HIV OR Other Malignancy
2) Age Below 18 Years And Above 30 Years
3) Complicated Acne With Infection Or The Patients Who Are Taking Medicines For Acne Since Long Time More Than 3 Months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It Will Reduce Yauvanpidika And Related Symptoms Like Daha Kandu And Vedana |
Patient Will Be Evaluated On Baseline 15th Day 30th Day 45th Day And On 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It Will Help To Increase Skin Tone |
Patient Will Be Evaluated On Baseline 15th DAy 30th day 45th Day And On 60th Day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
24/10/2022 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Yauvan Pidika (Acne vulgaris) is one of the most common dermatosis, which develop at puberty and young age, which are the wonder years of an individual’s life and when they are more conscious about the beauty. It leads to unattractive look and permanent disfigurement of the face, which may result in inferiority complex and sometimes isolation in the social life.
In Yauvan Pidika vitiation of Vata and Kapha Dosha along with Rakta Dhatu is described. Acharya Sushruta mentioned ‘Yauvan Pidika’ under the heading of “KSHUDRA ROGAâ€
Eruptions like Shalmali thorn on the face of a young person caused by Kapha, Vata and Rakta is known as Mukh-Dushika or YAUVANPIDIKA
The signs and symptoms of Yauvan Pidika can be correlated with ’Acne vulgaris according to modern view. Yauvana Pidika, the disease name itself shows that the disease almost takes place in young age. In this modern era Yauvan Pidika (acne) is the burning problem in the adolescence. Modern science believes that it is due to infection of certain organism, but the disease is no more a simple reaction to bacterial infection. It occurs due to stress, influence of endocrine glands of the body, particularly the ovary & testis. Sometime it occurs in particular race, age, nutritional status, temperature, excessive use of cosmetics. |