| CTRI Number |
CTRI/2023/06/053659 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/06/2023 |
| 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 capsule on Skin & Hair Health in Healthy adult |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Placebo
Controlled Clinical Study to Evaluate the Effects of
KSM-66 Ashwagandha® capsule (300 mg) on Skin
and Hair Health in Healthy Men & Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ixoreal-HS-CT-06-23, Version 1, dt. 14 Feb. 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shylaja Someshwar |
| 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.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9820500964 |
| Fax |
|
| Email |
mgmderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shylaja Someshwar |
| 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.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9820500964 |
| Fax |
|
| Email |
mgmderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shylaja Someshwar |
| 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.
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9820500964 |
| Fax |
|
| Email |
mgmderma@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 |
| Shylaja Someshwar |
MGM Medical College & Hospital |
MGM Medical Hospital, Dermatology department, Room no. 204, 2nd floor, Sector 1, Kamothe, Panvel Navi Mumbai.
Mumbai
MAHARASHTRA |
09820500964
mgmderma@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 60 years age
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KSM-66 capsules containing
Ashwagandha 300 mg
standardized root extract |
Standardized root extract 300
mg to be taken two times in a
day orally with water/milk for
period of 12 weeks |
| Comparator Agent |
Placebo Capsule (Identical to
intervention Capsule) |
Identical Capsule containing
starch 300 mg to be taken two
times in a day orally with
water/milk for period of 12
weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult men and women participants ≥ 18 years and ≤60
years of age.
2. Willingness to follow the protocol requirements as evidenced by
written informed consent.
3. Participants who were on consistent dietary, hair, and skin product
3 months prior to start of the study and are willing to follow the same
during the study.
4. 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.
5. 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.
6. Willing to come for all follow-up visits.
7. Participants who agree not to cut hair for the entire duration of the
study.
8. Participants willing to undergo Trichoscan evaluation and not to
wash their hair 48 hours before the visit.
9. Participants willing to take proper contraceptives during the study
and period.
10. Participants or LAR can and willing to give meaningful, written
informed consent prior to participation in the trial, in accordance
with regulatory requirements.
11. Participants who agree to take investigational product (i.e., Till Day
90 ± 4 ± 4).
|
|
| ExclusionCriteria |
| Details |
1. Participants having any clinically significant medical history,
medical finding including rosacea, eczema, psoriasis, and atopic
dermatitis or an on-going 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 (i.e.,
allergic or oversensitivity to study medication).
4. Participants who have undergone or plan to undergo hair
transplantation surgery during the study period.
5. Participants with facial skin cancer.
6. Participants with sunburn, moderate to pronounced suntan, uneven
skin tones, tattoos, scars or other disfiguration, dilated vessels or
other conditions on the test area that might influence the test results.
7. Participants with severe seborrheic dermatitis, alopecic disease,
except for androgenic alopecia, and scalp disorders, such as scalp
psoriasis and infection
8. Participants who have participated in a clinical study during the
preceding 180 days.
9. Participants having eating disorders (i.e., bulimia, psychogenic
eating disorders, etc.).
10. Pregnant and lactating females
11. Participants with alcohol addiction or persistent abuse of drugs of dependence. |
|
|
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 |
Trans Epidermal Water Loss (TEWL)
Assessment |
Baseline, 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trichoscan analysis
|
Baseline, 12 Weeks |
DLQI Questionnaire score
assessment
|
Baseline, 12 Weeks |
Hair Skindex-29 Questionnaire
score assessment |
Baseline, 12 Weeks |
Subjects Self-Assessment of
improvement
|
Baseline, 12 Weeks |
Clinical Global Impression – Improvement scale
(CGI-I) |
Baseline, 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not 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. 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. |