| CTRI Number |
CTRI/2025/08/092536 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Check the Safety and Effects of a Skin Patch (TDW) for Reducing Cravings and Increasing Fullness in Obese Adults. |
|
Scientific Title of Study
|
An Open-Label Pilot Study to Evaluate the Effects and Safety of the Satiety-Enhancing Topical Formulation TDW on Cravings and Satiety in Obese Adults. |
| Trial Acronym |
TOP-SAT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TDW/PILOT/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDipti Gupta |
| Designation |
Consultant Physician |
| Affiliation |
Tulsi Multispeciality Hospital. |
| Address |
B-1, Loni Rd, West Jyoti Nagar, Jyoti Nagar West, Jyoti Nagar, Shahdara, Delhi, 110094
New Delhi
DELHI
110094
India |
| Phone |
09811676049 |
| Fax |
|
| Email |
dr.dipti16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaitan Singh |
| Designation |
Project Manager |
| Affiliation |
VERISEARCH LAB PRIVATE LIMITED |
| Address |
VERISEARCH LAB PRIVATE LIMITED 705 QUANTUM TOWER RAMBAGH LANE BEHIND SBI MALADWEST, MaladWest Dely, Mumbai, Maharashtra, India 400064
Mumbai
MAHARASHTRA
400064
India
Mumbai
MAHARASHTRA
400064
India |
| Phone |
8826628182 |
| Fax |
|
| Email |
cro.verisearchlab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaitan Singh |
| Designation |
Project Manager |
| Affiliation |
VERISEARCH LAB PRIVATE LIMITED |
| Address |
VERISEARCH LAB PRIVATE LIMITED 705 QUANTUM TOWER RAMBAGH LANE BEHIND SBI MALADWEST, MaladWest Dely, Mumbai, Maharashtra, India 400064
Mumbai
MAHARASHTRA
400064
India
Mumbai
MAHARASHTRA
400064
India |
| Phone |
7827758840 |
| Fax |
|
| Email |
cro.verisearchlab@gmail.com |
|
|
Source of Monetary or Material Support
|
| VERISEARCH LAB PRIVATE LIMITED 705 QUANTUM TOWER RAMBAGH LANE BEHIND SBI MALADWEST, Malad West Dely,Mumbai, Maharashtra, India 400064 |
|
|
Primary Sponsor
|
| Name |
Urrth Naturals LLP |
| Address |
C-32 T/F Bhagwan Das Nagar ,New Delhi- 110026 |
| Type of Sponsor |
Other [nutraceutical] |
|
|
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 Dipti Gupta |
Tulsi Multispeciality Hospital. |
B-1, Loni Rd, West Jyoti Nagar, Jyoti Nagar West, Jyoti Nagar, Shahdara, Delhi, 110094
New Delhi
DELHI |
09811676049
dr.dipti16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CentralIndependentEthicsCommittee-CIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z683||Body mass index (BMI) 30-39, adult. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: TDW patch , Reference: NA, Route: Topical, Dosage Form: Lepa Gutika, Dose: 01(NA), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 01 Days, anupAna/sahapAna: No, Additional Information: TDW patch once daily |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
To participate in the study subjects must meet the following criteria
1 Age Male and female participants aged 25 to 60 years
2 Body Mass Index (BMI) BMI between 30.0 to 34.9 kilograms per square meter (Class I obesity)
3 Physical Activity Engaging in at least 30 minutes of moderate physical activity per day on most days of the week five or more days per week, and willing to maintain this activity level throughout the study period
4 Subjective Satiety Dysfunction Participants who score less than or equal to 19 on the Satiety Subscale of the New Zealand Eating Behaviour Questionnaire (NZ-EBQ) indicating moderate to poor satiety regulation
5 High Food Cravings Participants who score greater than or equal to 70 millimeters on VAS for Desire to Eat or Hunger OR self-report persistent cravings for unhealthy snacks despite regular meals
6.Subjective Hunger Index Baseline VAS score for Hunger greater than or equal to 60 millimeters out of 100 mm indicating elevated appetite levels.
7 Motivated for Diet Control Participants who selfreport difficulty adhering to a diet despite efforts at weight loss or dietary regulation
8 Consent and Compliance Willing and able to provide written informed consent and comply with all study procedures including daily application of the patch and completion of appetite mood questionnaires
|
|
| ExclusionCriteria |
| Details |
A subject will be considered unsuitable for the study if they meet any one of the following criteria:
1 Use of appetite suppressants or weight loss medications
2 Presence of metabolic disorders eg diabetes thyroid disease
3 Significant skin conditions or known allergies especially those that may interfere with topical applications
4 Recent participation in any weight loss programs or clinical trials
5 Pregnancy or lactation
6 Current smokers
7 Heavy alcohol consumption |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Improvement in satiety (measured by New Zealand Eating Behavior Questionnaire (NZ EBQ)
2 Reduction in cravings for snacking:
1 measured by Snacking Craving Scale Validated 3 Item VAS
2 measured by Visual Analogue Scale VAS Appetite Assessment |
Visit-1
Screening
(Day 0) Baseline
Visit-2
(Day 15) + 2 days
Visit-3 and EOS
(Day 45) + 2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Change in mood measured by Profile of Mood States POMS
2 Change in perceived stress measured by Perceived Stress Scale PSS
3 Adverse events and serious adverse events throughout the study
4 Local skin tolerability |
Visit1
Screening
Day 0 Baseline
Visit2
Day 15 plus 2 days
Visit-3 and EOS
Day 45 plus days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
18/10/2025 |
| Date of First Enrollment (Global) |
18/08/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open-label pilot clinical study designed to assess the effects and safety of a topical formulation, TDW, intended to enhance satiety and reduce food cravings in obese adults. The study will evaluate changes in self-reported satiety levels and cravings over the treatment period, along with monitoring for any adverse effects to determine the product’s tolerability and feasibility for further clinical development. |