| CTRI Number |
CTRI/2022/07/043866 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Skin and Comparative Study Of Lodhradi Lepa and
Shalmalikantak Lepa in the Management of Acne Vularis |
|
Scientific Title of Study
|
A Physiological Study Of Twak With Special Reference To Role
Of Lodhradi Lepa and Shalmalikantak Lepa in the Management
Of Yuvanpidaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Meena |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir,
National Institute of Ayurveda,Deemed to be University,Jaipur Skin Division,Room No.3
Department of Kriya Sharir,
National Institute of Ayurveda,Deemed to be University,Jaipur Skin Division,Room No.3
Jaipur
RAJASTHAN
302002
India |
| Phone |
9680357962 |
| Fax |
|
| Email |
sm4726706@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra Prasad |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir,National Institute of Ayurveda,Deemed to be University,Jaipur,Skin Division,Room No. 3
Department of Kriya Sharir,National Institute of Ayurveda,Deemed to be University,Jaipur,Skin Division,Room No. 3
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMahendra Prasad |
| Designation |
Associate Professor, |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kriya Sharir National Institute of Ayurveda Deemed to be University,Jaipur,Skin Division,Room No.3
Department of Kriya Sharir National Institute of Ayurveda Deemed to be University,Jaipur,Skin Division,Room No.3
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
jorawar singh gate amer road jaipur
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| sunita meena |
National Institute of Ayurveda,Jaipur |
OPD No. 3,Skin Division Department of Kriya Sharir,National Institute of Ayurveda,Deemed to be University,Jaipur
Jaipur
RAJASTHAN |
9680357962
sm4726706@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
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), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodharadi Lepa, Reference: Bhaushjya Ratnavalli, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - godugdha), Additional Information: - along with manjistha churna 3 g per day morning and evening for 30 days with luke warm water | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shalamalli kantak lepa, Reference: Yogratnakar, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: - Godugdha), Additional Information: -along with Manjistha churna 3 g morning and evening with luke warm water for 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject in the age group of 18-40 years irrespective to sex.
2.Subject with sign and symptoms of Yuvanpidaka . |
|
| ExclusionCriteria |
| Details |
1. Known case of any systemic or skin diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Global Acne Grading System. |
36 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Increase the complexion and smoothness of the face.
- Relief in sign and symptoms(kandu,ruja daha,shrava,vaivarnya |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2022 |
| 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="6"
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
|
The skin covers the external surface of the body and is the largest organ in both surface area and
weight. It is metabolically active with vital function protection and maintaining homeostasis of the
body. There are many conditions that affect skin. Acne is one type of skin related problem. Acne
Vulgaris is an extremely common condition with a lifetime prevalence of approximately 85% and
occurs mostly during adolescence.Acne vulgaris can persist into adulthood, with a 50.9% prevalence
rate of acne in women ages 20 to 29 years versus 26.3% in women ages 40 to 49 years.
-Acne is the major problems at the puberty age. In Conventional Medical treatment there is no
satisfactory results seen in its treatments and has different adverse effects on the body like redness
and dryness of skin, skin irritation, skin discoloration, loss of appetite, hepatotoxicity, etc. So it is
the need of hour to use natural non-toxic remedies to bring the skin into normal state., So it is
necessary to study the normal physiology of Twacha for understanding the pathology of Yuvanpidaka
and its management.
SELECTION OF DRUG
Ayurveda has a great potential in the management of Yuvanpidaka and its associated complications.
Keeping in mind the etio-pathogenesis of Yuvanpidaka, Manjistha Churna should be used which
stimulates Dhatwagni. Its Kapha-Pittahara properties pacify the aggravated Kapha, Rakta and Vata
Dosha. Acharya Vagbhatt recommends Lepa as first line of treatment. Lepa is beneficial in terms of
its time duration, easy administration and cost effective.
Many texts HHmentioned medications for Yuvanpidaka which need to be tested and validated
scientifically. Different Acharyas have indicated different Lepa, Raktasodhak medication and
Siravedha Karma in Yuvanpidaka. Acharya Sushruta has advised Lepa, Sodhan therapy, Siravedha
Karma in Yuvanpidaka. ..
The formulations Lodhradi Lepa and Shalmalikantak lepa with possess properties required for the
management of Yuvanpidaka. So, after reviewing the literature and keeping in mind the DoshaDushya of Yuvanpidaka, these drugs have been choosen for the study.
AIM -
To study Physiology of Twak and Effect of Lodhradi lepa and Shahlmali kantak lepa in
the management Yuvan pidaka.
OBJECTIVES
1) To study the physiological concept of Twak with special reference to Yuvanpidaka.
2) To evaluate the efficacy of Lodhradi lepa in Yuvanpidaka.
3) To evaluate the efficacy of Shalmalikantak lepa in Yuvanpidaka.
4) To compare the efficacy of Lodhradi lepa and Shalmalikantak lepa in Yuvanpidaka.
HYPOTHESIS
NULL HYPOTHESIS (H0)
There is no difference between the role of Lodhradi lepa and Shalmalikantak lepa in Yuvanpidaka. |