| CTRI Number |
CTRI/2023/03/050307 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study to evaluate safety and efficacy of HSTF 02206 in reduction of dark spots |
|
Scientific Title of Study
|
A clinical observational study to evaluate Safety and Efficacy of HSTF-022206 in
Healthy Adult Subjects in reduction of facial dark spots. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/CPD/001/2023, dated 14 Feb 2023, version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Sohandas Shetty |
| Designation |
Principal Investigator |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
KARNATAKA
560083
India |
| Phone |
8867125414 |
| Fax |
|
| Email |
drsohanshetty@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena Dalal |
| Designation |
CRO Representative |
| Affiliation |
Trial Guna Pvt Ltd |
| Address |
467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA
560083
India |
| Phone |
9972636265 |
| Fax |
|
| Email |
meena@trialguna.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company
Makali,Bengaluru 562 162,
India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Makali,
Bengaluru 562 162,
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 Sohandas Shetty |
TrialGuna Private Limited |
467, 2nd floor,1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka
Bangalore
KARNATAKA |
8867125414
drsohanshetty@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: licorice, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 18 to 55 years (both inclusive) at the time of consent.
2. Sex: Healthy non-pregnant/non-lactating females and Males.
3. Subject has facial dark spots includes sun-tan, blemishes,
sunspots, and age spots.
4. Female of childbearing potential must have a reported negative
pregnancy during screening.
5. Subject is generally in good health.
6. Subject has not undergone any cosmetic procedures or any
medication for the treatment of acne or facial dark spots 3
months prior to study enrolment and willing to forgo any
treatment duration of the study |
|
| ExclusionCriteria |
| Details |
1.Subject has a history of allergy or sensitivity to the test treatment ingredients
2.Subject who has a history of allergy with products containing
turmeric or any known ingredients.
3. Subject who has pre-existing or dormant dermatologic
conditions (e.g., psoriasis rashes, eczema, seborrheic dermatitis,
acne, acne rosacea or any other) that could interfere with the
subject selection and outcome of the study as determined by
the Investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in dark spots
2.Improvement of PGA scoring
3.Change in skin appearance
4.Safety of skin |
Day 1,Day 7,Day 14,Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the product safety of skin by local intolerance
evaluation by investigator and occurrence AEs and SAEs. |
Day 1,Day 7,Day 14,Day 28 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/03/2023 |
| Date of Study Completion (India) |
07/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
An open-label, single-arm, single-centre clinical observational study to evaluate Safety and Efficacy of HSTF-022206 in Healthy Adult Subjects in adult human subjects from 18 to 55 years with facial dark spots. Subjects will be pre-screened by the study team. Subjects will be telephonically contacted by recruiting team prior to the enrolment visit. Subjects will be instructed during screening (prior to enrolment) not to wear any facial make-up during study visit to facility. The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. The subjects will be instructed to visit the facility as per the below visits. ✓ Visit 1 (Day 1): Screening and Enrolled Day 1 ✓ Visit 2 (Day 7): Product usage Period, Evaluation Visit ✓ Visit 3 (Day 14): Product usage Period, Evaluation Visit ✓ Visit 4 (Day 28): Product usage Period End, End of the Study visit. |