| CTRI Number |
CTRI/2022/11/047539 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Evaluate the effect and Safety of Ashwagandha Serum on the hair health in healthy adult humans. |
|
Scientific Title of Study
|
A Prospective, Double-Blind, Randomized, Parallel, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha topical formulation (Serum) on the hair health in healthy adult humans. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IB-HH-CT08-22 Version 01 Dated 06-Sep-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chinmai Yerram |
| Designation |
Principle Investigator |
| Affiliation |
Skintis Clinic Medical and Cosmetic Dermatology and Gynaecology |
| Address |
Skintis Clinic Medical and Cosmetic Dermatology and Gynaecology 7/56/19
SBR SIRI Building, Unit no 204, Second floor, Dargah Rd, Raidurg, Radhenagar,
Gachibowli, Hyderabad, Telangana 500035
Hyderabad
TELANGANA
500035
India |
| Phone |
9515378114 |
| Fax |
|
| Email |
chinmayi.yerram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sornaraja Thasma |
| Designation |
Director of Quality Assurance |
| Affiliation |
ProRelix Services LLP |
| Address |
Prorelix Services LLP 102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052
Pune
MAHARASHTRA
411052
India |
| Phone |
8124806366 |
| Fax |
|
| Email |
s.thasma@prorelixresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sohal Pendse |
| Designation |
Director of Business Operations |
| Affiliation |
ProRelix Services LLP |
| Address |
Prorelix Services LLP 102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052
Pune
MAHARASHTRA
411052
India |
| Phone |
9890096725 |
| Fax |
|
| Email |
s.pendse@prorelixresearch.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed, Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills
Hyderabad, Telangana 500033 India. |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed |
| Address |
Ixoreal Biomed, Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills
Hyderabad, Telangana 500033 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 Chinmai Yerram |
Skintis Clinic Medical and Cosmetic Dermatology and Gynaecology |
7/56/19 SBR SIRI Building, Unit no 204, Second floor, Dargah Rd, Raidurg,Radhenagar,
Gachibowli, Hyderabad, Telangana 500035
Hyderabad
TELANGANA |
9515378114
chinmayi.yerram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Deccan Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair-fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KSM-66 Ashwagandha Hair serum |
KSM-66 Ashwagandha Hair serum 2 drops (2ml) applying the hair serum daily once for 75 days |
| Comparator Agent |
Placebo serum |
Applying the hair serum daily once for 75 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult healthy male/ female participants more than equal to 18 years and less than equal to 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.
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 are able to 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 75 ± 4). |
|
| ExclusionCriteria |
| Details |
1.Participants having any clinically significant medical history, medical finding
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 aplha-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
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in hair analysis parameter, hair density (n/cm2 ), hair diameter
(µm), hair growth rate (mm/day), or anagen/telogen ratio ( Hair Analysis by
Trichoscan) from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day
1) to Visit 3, End of study (Day 75 ± 4).
Mean change in the shedding range of the hair in the “60 Second Hair Comb
test†from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to
Visit 3, End of study (Day 75 ± 4). |
Baseline and Day 75 ± 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change in (hair thinning and hair fall assessment) IGA scale score from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4)
2. Change in mean levels of shedding range of the hair via hair pull test from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4).
3. Mean change in QoL (hair-specific Skindex-29 scores from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4).
4. Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 11 weeks’ treatment period |
Baseline and Day 75 ± 4 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2022 |
| Date of Study Completion (India) |
14/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sixty-eight healthy male and female of age more than equal to 18 years and less than equal to 45 will be assigned in 1:1 ratio to treatment with the test product, KSM-66 Ashwagandha Hair serum or Placebo in this double-blind, randomized, placebo-controlled study. All 68 enrolled subjects will be asked to add 1 to 2 drops (2ml) of KSM-66 ashwagandha hair serum or identical placebo formulation to the palm of hand, and apply it to hair, working from the ends up to the middle of the hair strands. For best results, apply your initial application of hair serum to clean, damp hair. Subjects will be required to apply daily once for 75 days at home. Subjects will be required to use diaries to document the date, time and dosage of the study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with Mean Changes in Hair analysis parameters and 60 seconds hair comb test will be evaluated and secondarily IGA score, hair pull test, Hair-specific Skindex-29 score will be evaluated at the baseline visit and at the End of study. |