| CTRI Number |
CTRI/2023/07/055432 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of herbal formulation on hair health |
|
Scientific Title of Study
|
Clinical Study to evaluate the Herbal formulation for its action in promoting Healthy hair growth and minimizing Hair losses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Senior assistant professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.115C, P.G. Department of Panchakarma National Institute of Ayurveda, Amer road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarvesh kumar singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.113A,P.G Department of Panchakarma National Institute of Ayurveda Madhav vilas Amer road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarvesh kumar singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.113A,P.G Department of Panchakarma National Institute of Ayurveda Madhav vilas Amer road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
08739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Plantayu life science LLP |
|
|
Primary Sponsor
|
| Name |
Plantayu life science LLP |
| Address |
A1 301 Wonderwall, Concord Portia Lane
Balewadi, Pune 411045 Maharashtra India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sarvesh Kumar Singh |
National Institute of Ayurveda, |
Room no.113 C, Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Amer Road,
Jaipur (Raj.) – 302002
Jaipur
RAJASTHAN |
08739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee national institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L659||Nonscarring hair loss, unspecified. Ayurveda Condition: KHALITYAM/KHALATI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: PLHO, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -oil will be applied twice a week with atleast 2 days gap | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: coconut oil, Reference: Bhisajya ratnawali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -oil will be applied twice a week with atleast 2 days gap |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 18 - 60 yrs
2. Male or female
3. Willing to provide voluntary written informed consent.
4. Patients having self-reported thinning or hair loss for more than 6 months prior to screening
5. Patient clinically confirmed to have hair loss or thinning though physical exam ( for female pattern hair loss Savin Classification score of I 2-II 1,[4] for male pattern hair loss Norwood-Hamilton classification score I, II, III) [5]
6. Patient willing to maintain same hair style, hair color, and hair regimen throughout the study and use mild non medicated shampoo during the study period.
7. Women of child bearing age willing to adopt medically sound method of birth control during the trial period.
|
|
| ExclusionCriteria |
| Details |
1. Clinical diagnosis of alopecia areata or scarring forms of alopecia or hair loss due to disease, injury or medical therapy
2. Patient hypersensitive to study product or hair dye and its component.
3. History of hair transplant.
4. Patients with diagnosed organic disease of scalp with dermatological origin (other than mild to moderate dandruff determined by Adherent Scalp Flaking Score) like psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis which requires medication.
5. Pregnant or lactating women
6. Diagnosis of organic diseases including Uncontrolled diabetes mellitus (DM), endocrinal disorder, Hypertension, neoplastic, severe cardiovascular diseases, renal insufficiency, psychiatric disorders, iron deficiency, coagulopathies etc or on any medication that can cause potential hair loss or affects hair growth.
7. Refusal to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate changes in Target Area Hair Count (TAHC) measured by Dermobella hair analyzer. |
base line to 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To analyze changes in number of hair loss in comb test & pull test, subjective assessment of hair health variables though Modified Self-assessment questionnaire, effect on dandruff through Adherent Scalp Flaking Score (ASFS), acceptability of hair oil formulation though modified topical product usability questionnaire, Safety will be assessed at all visits through vital signs and scalp evaluations for symptoms of irritation and self observed and reported Adverse events (aes). |
base line to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| Date of Study Completion (India) |
11/05/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present work is undertaken to assess the action of herbal formulations in promoting hair growth and minimizing hair losses.The study population was 60 healthy volunteers randomly divided in two equal groups of 30 individuals each. Group A:- Subjects were advised to apply 5-10ml solution on Scalp/area once a day. Group B:- Subjects were advised to apply Standard formulation as per prescribed dosage once a day. |