| CTRI Number |
CTRI/2022/12/048388 [Registered on: 22/12/2022] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial of Hair care supplements |
|
Scientific Title of Study
|
A parallel arm clinical trial to validate safety and efficacy of Hair care product range (LS/HC/001) in adult females. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LS/21-22/001 Version 1, dated 25 March 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ninad Naik |
| Designation |
Consultant |
| Affiliation |
Atharv Medical Research Center |
| Address |
Shirode Rd opp. krishna
chowk Kirti Nagar New Sanghavi
Pune
MAHARASHTRA
411027
India |
| Phone |
9422089260 |
| Fax |
|
| Email |
drnaik2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Vaishnavi Padar |
| Designation |
Project coordinator |
| Affiliation |
Life Synergy |
| Address |
501, 514, Crossroad, Wakad, Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
9834585994 |
| Fax |
|
| Email |
vaishnavi.mprexhc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vaishnavi Padar |
| Designation |
Project coordinator |
| Affiliation |
Life Synergy |
| Address |
501, 514, Crossroad, Wakad, Pune
Pune
MAHARASHTRA
411057
India |
| Phone |
9834585994 |
| Fax |
|
| Email |
vaishnavi.mprexhc@gmail.com |
|
|
Source of Monetary or Material Support
|
| LifeSynergy, 203, Wing F, Second floor, Austin County, Tathawade, Pune 411057 |
|
|
Primary Sponsor
|
| Name |
Life Synergy |
| Address |
203, Wing F, Second floor, Austin County, Tathawade, Pune 411057 |
| 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 Ninad Naik |
Atharv Medical Research Center |
Second Floor Shirode Rd opp krishna chowk Kirti Nagar New Sanghavi 411027
Pune
MAHARASHTRA |
9422089260
drnaik2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair related complaints |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LS/HC/OR/001 |
1-2 capsules twice daily orally for 90 days |
| Intervention |
LS/HC/OR/001 and LS/HC/TP/001 |
1-2 capsules of LS/HC/OR/001 twice daily orally for 90 days along with sufficient amount of serum/ elixir (LS/HC/TP/001) to roots and entire length of hair daily for 90 days |
| Intervention |
LS/HC/TP/001 |
Apply sufficient amount of serum/ elixir to roots and entire length of hair daily for 90 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects in general good health, subjects in the age group 18-60 years, subjects willing to to give written informed
consent and agree to come for a regular follow up visit, subjects not
participated in a similar investigations in the past two weeks,
subjects complaining of hair fall and damage, subjects who are not
on crash dieting, subjects who agree to not to change the brand of
currently used hair color, dye, treatment etc., if during the study term,
subjects willing to refrain from any type of hair treatment like head
massage, oil application, perming, etc. during the study duration,
subjects with at least of two of following complaints- hair loss, dry damaged
hair, brittle and thin hair, premature greying of hair, scalp related complaints like itching, dandruff or irritation |
|
| ExclusionCriteria |
| Details |
Subjects who are undergoing hair growth treatment within 3 months before screening into the study.
Subjects having any active scalp disease which may interfere in the study.
Subjects on treatment for active acne
Subjects with history or active phase of malignancy and chemotherapy therefore.
Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
Subjects who have had hair transplant.
Subjects who take pharmaceutical product which cause hirsutism.
Subjects on oral hair growth medications which will compromise the study.
Subjects who are pregnant lactating or nursing as established with medical history.
Chronic illness which may influence the study.
Subjects participating in other similar cosmetic or therapeutic trial within last two weeks
Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anaemia, serious disorder of heart and respiratory apparatus or any other serious medical illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in number of shredded hairs in 60 second Hair comb test
Changes in number of shredded hairs in Hair wash test
Assessment by photo trichogram-
-% Anagen and telogen Hair
-Hair density and thickness
-Terminal and vellus hair density
-Hair growth rate (mm/day)
Skin health assessment by CLBT score |
From baseline to day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess nail growth and satisfaction scale on nail health
To assess improvement in the “Hair Quality Assessment Questionnaire†from baseline to End of the study. (Brittleness, thinning, dryness and damaged hair, luster, roughness, fizziness)
To assess VAS- Visual analog scale scalp related complaints like itching, dandruff or irritation (Scalp health) tolerability including the ocular irritant potential and non-irritant potential on skin |
From baseline to day 90 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/12/2022 |
| 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="0"
Months="5"
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)?
Response - NO
|
|
Brief Summary
|
Considering the etiological basis of hair loss and hair and scalp-related complaints in nutritional deficiencies, the interventions like micronutrients and phytoconstituent blend can promote hair, nail and skin-related health. The current study is to validate the safety and efficacy of hair care supplements in healthy female subjects with hair and scalp related complaints |