| CTRI Number |
CTRI/2023/03/051000 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hair dyeing effect of classical preparation of Nymphaea rubra Roxb. in Gray Hair. |
|
Scientific Title of Study
|
An Evaluation of Kesha Krishnikarana effect of Nymphaea rubra Roxb. in the management of Gray Hair. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patel Kruti Dipakkumar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved Parul University |
| Address |
Department of Dravyaguna
Parul Institute of Ayurved
Parul University
Post-Limda
Tal-Waghodia
Dist-Vadodara
Gujarat-391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
7975986220 |
| Fax |
|
| Email |
krutipatel7508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Parmar |
| Designation |
MD Dravyaguna, HOD |
| Affiliation |
Parul Institute of Ayurved Parul University |
| Address |
Departent of Dravyaguna
Parul Institute of Ayurved
Parul University
Post-Limda
Tal-Waghodia
Dist-Vadodara
Gujarat-391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9724306523 |
| Fax |
|
| Email |
rekha.parmar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Patel Kruti Dipakkumar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved Parul University |
| Address |
Department of Dravyaguna
Parul Institute of Ayurved
Parul University
Post-Limda
Tal-Waghodia
Dist-Vadodara
Gujarat-391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
7975986220 |
| Fax |
|
| Email |
krutipatel7508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved Parul University
Post-Limda
Tal-Waghodia
Dist-Vadodara
Gujarat-391760
India |
|
|
Primary Sponsor
|
| Name |
Dr Patel Kruti Dipakkumar |
| Address |
Department of Dravyaguna
Parul Institute of Ayurved Parul University
Post-Limda
Tal-Waghodia
Dist-Vadodara
Gujarat-391760
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Patel Kruti Dipakkumar |
Parul Ayurved Hospital |
OPD No 115
Swasthavritta Department
Parul Ayurved Hospital
Parul University
Post-Limda
Tal-Waghodia
Dist-Vadodara
Gujarat-391760
India
Vadodara
GUJARAT |
7975986220
krutipatel7508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L671||Variations in hair color. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hair dye of Nymphaea rubra Roxb., Reference: Vrinda Madhav, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Hair dye of Nymphaea rubra Roxb. will be applied on wet hair,forming a paste with optimum quantity of water. It will be left for 1 hour for complete drying. Then it will be removed by washing with plain water. It will be advised to apply this once a week for a period of 1 month. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hair dye of Nymphaea rubra Roxb., Reference: Vrinda Madhav, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Hair dye of Nymphaea rubra Roxb. will be applied on wet hair, forming a paste with optimum quantity of water. It will be left for 2 hour for complete drying. Then it will be removed by washing with plain water. It will be advised to apply this once a week for a period of 1 month. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Healthy volunteers having gray hair
2)Volunteers willing to sign the informed consent |
|
| ExclusionCriteria |
| Details |
1)Persons having any skin diseases and wound
2)Any history of Allergy
3)Hypersensitivity of skin
4)Any major diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hair dye of Nymphaea rubra Roxb. is effective as Kesha Krishnikarana in Gray Hair |
After 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ayurvedic literature validation |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Hair colouring or dying has been a common thing today. Some use hair dyes to cover up the gray hair, to bring back the lost colour due to age, or to simply add colours to liven it up. 2. Hair dyes may cause allergic reaction, hair fall, brittle hair, irritable skin, rashes, asthma. It also have carcinogenic effect. 3. As Nymphaea rubra Roxb. is a herbal drug, chances of causing side effects are very less. 4. This study is to prepare natural hair dye with the help of classics and it is easy to use.
|