| CTRI Number |
CTRI/2018/10/016087 [Registered on: 22/10/2018] Trial Registered Prospectively |
| Last Modified On: |
17/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ayurvedic Shampoo and Conditioner on Dandruff |
|
Scientific Title of Study
|
Formulation and Evaluation of Ayurvedic Shampoo and Conditioner W.S.R. Anti-dandruff Activity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vatsala jain |
| Designation |
MD scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Rasshastra and Bhaishajya Kalpana National Institute of Ayurveda jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08989416316 |
| Fax |
|
| Email |
drvatsalajain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
vatsala jain |
| Designation |
MD scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Rasshastra and Bhaishajya Kalpana National Institute of Ayurveda jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08989416316 |
| Fax |
|
| Email |
drvatsalajain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vatsala jain |
| Designation |
MD scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Department of Rasshastra and Bhaishajya Kalpana National Institute of Ayurveda jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08989416316 |
| Fax |
|
| Email |
drvatsalajain@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda Madhav Vilas Palace Amer road
Jorawar singh gate Jaipur pincode 302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ministry Of AYUSH |
Ministry of AYUSH AYUSH Bhawan B Block GPO complex INA New Delhi 110023 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof K Shankar Rao |
National Institute of Ayurveda |
Rasshastra and Bhaishajya Kalpana department National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN |
9887181781
headrasa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic Shampoo and Conditioner |
This Anti-dandruff Ayurvedic shampoo is an oil in water type of emulsion containing 10% of active ingredients and 90% of base Active ingredients consists of Gomutra and extract of herbs like Shikakai reetha jatamansi Sariva Mandookparni Bhringaraj was used and base contained distil water surfactants fragrance etc and Conditioner is also oil in water type of emulsion containing 10% active ingredients 90% base active ingredients consists extract of Ushir Nagarmotha Nagkeshar hareetki and base contained distil water surfactants conditioning surfactants fragrance etc
5 to 7 gm shampoo with water will be applied on hair and scal locally for five minutes and than rinse with water and after that 2 to 5 gm conditioner will be applied on scalp and hair for 5 minutes and than rinse with water |
| Comparator Agent |
Reetha Powder |
5 gm Reetha Powder dipped in water left the mixture over night strained it in the morning apply on scalp and hair and after 5 to 10 minutes rinse with water |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
simple form of seborrhic dermatitis
confirmed cases of dandruff on the basis of observed signs and symptoms |
|
| ExclusionCriteria |
| Details |
Psoriasis
Cradle cap
Tenia capitis
Contact dermatitis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameter |
Patient will be examined every week for relief in dandruff |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from Dandruff |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2018 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dandruff is chronic scalp condition characterized by, scaling, itching and redness of scalp. In the 21st century it is evident that the problem of dandruff has become more common due to many reasons like drastic increment in pollution, irregular life style and most importantly hazardous use of chemicals to treat problems. According to 2016 study, Bacteria (Propioni bacterium and staphylococcus) are more important to formation of dandruff than fungi . keeping this in mind all the ingredients are selected to formulate anti-dandruff Ayurvedic Shampoo and Conditioner. Patients will be divided into two groups first will receive Ayurvedic Shampoo and Conditioner and second group will receive Reetha powder. |