| CTRI Number |
CTRI/2019/12/022529 [Registered on: 27/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| 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
|
EffECT OF SHWETA CHANDANADI LEPA AND KINSUKADI TAILAM IN SKIN ALLERGY DUE TO COSMETIC PRODUCTE |
|
Scientific Title of Study
|
A Comparative Clinical Study on Effect of Shweta Chandanadi Lepa and Kinsukadi Tailam In Twak pratyurjata W.S.R to Cosmetic Induced Skin Allergy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika Sharma |
| Designation |
Ph.D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Dept. of Agad Tantra ,National Institute of Ayurveda, Amer Road Jaipur
P.G. Dept. of Agad Tantra ,National Institute of Ayurveda, Amer Road Jaipur
Jaipur
RAJASTHAN
302002.
India |
| Phone |
9587408126 |
| Fax |
|
| Email |
sharmania64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANITA SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Dept. of Agad Tantra ,National Institute of Ayurveda, Amer Road Jaipur
P.G. Dept. of Agad Tantra ,National Institute of Ayurveda, Amer Road Jaipur
Jaipur
RAJASTHAN
302002.
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
Anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Sharma |
| Designation |
Ph.D Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
P.G. Dept. of Agad Tantra ,National Institute of Ayurveda, Amer Road Jaipur
P.G. Dept. of Agad Tantra ,National Institute of Ayurveda, Amer Road Jaipur
Jaipur
RAJASTHAN
302002.
India |
| Phone |
9587408126 |
| Fax |
|
| Email |
sharmania64@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Amer Road Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace,Amer Road, Jaipur, Rajasthan 302002 |
| 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 |
| Monika Sharma |
National Institute of Ayurveda |
Opd no-25, Department of Agad Tantra,Madhav Vilas Palace,Amer Road, Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN |
9587408126
sharmania64@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: L232||Allergic contact dermatitis due tocosmetics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External use of Shweta Chandanadi Lepa and Kinsukadi Tailam in cosmetic induce skin allergy |
Duration – 2 month
Dose – 1. Lepa once daily for 2 month with honey
2. 40 ml/ week oil for external use
|
| Comparator Agent |
Interna use of Manjisthadi kwath in cosmetic induce skin allergy |
Duration-2 month
dose-40 ml kwath twice daily |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients having complaint skin allergy due to use of any cosmetics and of clinical features like redness itching, urticaria, rashes will be selected for this clinical trial.
2.Patients of age group 20-70 years of either gender visiting the OPD and willing to provide written, informed consent will be selected to the study on basis of specially prepared Performa including relevant parameters.
3.Patients will be selected randomly, irrespective of gender, economical, educational and marital status.
4.Patient ready to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
➢ Patients not ready to give an informed consent.
➢ Patients not fulfilling the inclusion criteria.
➢ Patients who have been diagnosed to have local disease like burn, psoriasis leucoderma, leprosy, herpes, measles.
➢ Patients suffering from any kind of Malignancy, Diabetes, Cardiac disorder, HIV etc.
➢ Patients who are on steroids or there is history of prolonged steroid use or chemo-therapeutic agents
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Skin Allergy |
3 Month ,15 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Contact dermatitis |
6 Month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/01/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
The study is a Randomized comparative clinical and open-label study to compare the effect of the Shweta chandanadi lep and s Kinshukadi Tailam in cosmetic induce skin allergy.
Grouping for Clinical Study: 90 clinically diagnosed and registered patient of Cosmetic induced skin allergy will be divided randomly into two groups. Each group will have 45 patients. GROUP A: 45 clinically diagnosed and registered patient of skin allergy will be treated by local application of Shweta chandanadi lepa and internal use of Manjisthadi kwath Duration – 2 month Dose – 1. Lepa once daily for 2 month with honey 2. 40 ml Kwath twice daily GROUP B: 45 clinically diagnosed and registered patient of skin allergy will be treated by local application of Kinshukadi Tailam and internal use of Manjisthadi kwath Duration – 2 month Dose – 1. 40 ml/ week oil for external application 2. 40 ml Kwath twice daily FOLLOW UP Follow up of the patients will be taken at every 15 days interval for 60 days i.e. 1st day, 15 days, 30 days, 45 days and 60 days of study. |