| CTRI Number |
CTRI/2023/06/053920 [Registered on: 15/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Ashwagandha Serum on the Hair Health in Adults |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy
and Safety of Ashwagandha Serum Application on the
Hair Health in Healthy Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ixoreal-Hair-CT-04-23, Version 1, dt. 14 Feb. 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghana Phiske |
| Designation |
Principle investigator |
| Affiliation |
MGM Medical College and Hospital |
| Address |
MGM Medical Hospital, Dermatology department, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9819030429 |
| Fax |
|
| Email |
phiskemeghana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meghana Phiske |
| Designation |
Principle investigator |
| Affiliation |
MGM Medical College and Hospital |
| Address |
MGM Medical Hospital, Dermatology department, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9819030429 |
| Fax |
|
| Email |
phiskemeghana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meghana Phiske |
| Designation |
Principle investigator |
| Affiliation |
MGM Medical College and Hospital |
| Address |
MGM Medical Hospital, Dermatology department, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Mumbai
MAHARASHTRA
410209
India |
| Phone |
9819030429 |
| Fax |
|
| Email |
phiskemeghana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited, 5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91) 40-23204385 / 86 / 87 India
|
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91)
40-23204385 / 86 / 87 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 |
| Meghana Phiske |
MGM Medical College & Hospital |
Dermatology department, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Raigarh
MAHARASHTRA |
9819030429
phiskemeghana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male and Female 18 to 45 years of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha topical
formulation |
Ashwagandha topical serum to
be applied two times daily for 90 days |
| Comparator Agent |
Identical Placebo formulation |
Identical Placebo serum to be applied two times daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult healthy male/ female participants ≥ 18 years and ≤45 years of age.
2. Willingness to follow the protocol requirements as evidenced by written informed
consent.
3. Participants who agree not to use any medication (prescription and over the counter),
including vitamins and minerals, during or before the course of this study.
4. Participants with mild to moderate hair loss classified as the Norwood-Hamilton type II, III, IV and V in males and Ludwig type I and II in females.
5. Participants willing to come for all follow-up visits.
6. Participants agreeing for not cutting hair for the entire duration of study.
7. Participants willing to undergo Trichoscan preparation and not to wash their hair 48
hour before the visit.
8. Participants willing to follow consistent dietary, hair product usage during the study.
9. Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
10. Participants who agree to take investigational product (i.e., Till Day 90 ± 4) |
|
| ExclusionCriteria |
| Details |
1. Participants having any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator
could jeopardize the safety of the subject, impact validity of the study results or interfere
with the completion of study according to the protocol.
2. Participants on any medication or supplement for hair loss, including finasteride, any
other 5 α-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3
months prior to study commencement.
3. Participants having a history of hypersensitivity reactions.
4. Participation in a clinical study during the preceding 180 days
5. Participants who have undergone or plan to undergo hair transplantation surgery during
the study period.
6. Pregnant and lactating females.
7. Participants with severe seborrheic dermatitis, alopecic disease (except for androgenic
alopecia) and scalp disorders, such as scalp psoriasis and infection.
8. Participants with any disease or condition of the skin that the investigator deems
inappropriate for participation, including rosacea, eczema, psoriasis, and atopic
dermatitis.
9. Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 60 Second Hair Comb test |
Baseline, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MSCR 10-point scale score
|
Baseline, 12 weeks |
| Hair pull test score |
Baseline, 12 weeks |
| Hair-specific Skindex-29 |
Baseline, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/06/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. The efficacy assessments mentioned above will be done appropriately during the study. All Subjects will be followed-up during the study period (Screening /Baseline, Day-45 (telephonic),
and Day 90 ± 4) till complete the course of treatment. |