| CTRI Number |
CTRI/2022/06/043272 [Registered on: 15/06/2022] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Kumkumadi Ghrit in Facial dark patches. |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Kumkumadi Ghrit in participants suffering from Facial hyperpigmentation- An open label, non-comparative, interventional, prospective, clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KUMKUMGHR/NAMSKARAYU/2022/1, Version 1.0, 25th April 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ghate Vandana Bapurao |
| Designation |
Professor and HOD, |
| Affiliation |
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
| Address |
OPD No. 1, Ground floor, Department of Kayachikitsa, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur – 413512.
Latur
MAHARASHTRA
413512
India |
| Phone |
9822008324 |
| Fax |
|
| Email |
vandanaghate6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Namaskar Ayurved Private Limited,
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013 |
|
|
Primary Sponsor
|
| Name |
Namaskar Ayurved Private Limited |
| Address |
Unit - 4, Ground Floor,Peninsula Chambers
Peninsula Corp Park G K Marg Lower Parel
Mumbai-400013
|
| 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 Ghate Vandana Bapurao |
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital |
OPD No. 1, Ground floor, Department of Kayachikitsa, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur – 413512.
Latur
MAHARASHTRA |
9822008324
vandanaghate6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: NILIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kumkumadi Ghrit, Reference: Bhaishajya Ratnavali, Kshudra Roga., Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be advised to apply Kumkumadi Ghrit on face and massage for 1 minute once daily for a period of 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed mild to moderate facial hyperpigmentation
2. Willing to comply with all requirements of the study including being photographed, at baseline and following post treatment care and attending all treatment and follow up visits
|
|
| ExclusionCriteria |
| Details |
1. Subjects who have received facial treatments within the past three months, including laser, RF (radio frequency), HIFU (high-intensity focus ultrasound), or dermal filler injection.
2. Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea
3. Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs within 21 days before entering the trial
4. Subjects on any other investigational products within 1 month prior to randomization
5. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
6. Pregnant women
7. Known hypersensitivity to any of the ingredients of Kumkumadi Taila
8. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in facial hyperpigmentation |
Screening / Baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 15), visit 4 (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in photographic evaluation of Facial hyperpigmentation spot
2. Change in skin lightening effect
3. Change in skin glow
4. Assessment of 24 hr skin patch test
5. Change in facial cutaneous moisturization
6. Changes in facial wrinkles
7. Difference in number of comedones
8. Assessment of ability of Kumkumadi Ghrit to absorb into the skin
9. Assessment of oily/greasy appearance of skin after application of Ghrit
10. Assessment of feeling of Ghrit on skin
11. Global assessment for overall change
12. Assessment of post treatment tolerability of study drug
13. Assessment of adverse events
|
Screening / Baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 15), visit 4 (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2022 |
| Date of Study Completion (India) |
20/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Kumkumadi Ghrit in participants suffering from facial hyperpigmentation. Subjects will be advised to apply Kumkumadi Ghrit on face and massage for 1 minute once daily for a period of 30 days. The primary objective of the study will be to assess change in facial hyperpigmentation. Secondary objectives of the study will be to assess changes in photographic evaluation of Facial hyperpigmentation spot, change in skin lightening effect, change in skin glow, assessment of 24 hr skin patch test, change in facial cutaneous moisturization, changes in facial wrinkles, difference in number of comedones, assessment of ability of Kumkumadi Ghrit to absorb into the skin, oily/greasy appearance of skin after application of ghrit, feeling of Ghrit on skin, global assessment for overall change, assessment of post treatment tolerability of study drug and assessment of adverse events on screening / Baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 15), visit 4 (Day 30)
Results and Conclusion:
Kumkumadi Ghrit showed significant reduction in facial hyperpigmentation
(dark spots). It also showed skin lightening effect with significant
improvement in skin glow, facial moisturization, reduction in facial wrinkles
and comedones.
Use of Kumkumadi Ghrit was also found to be safe without
producing any adverse effects. Kumkumadi Ghrit can therefore be recommended as a safe and effective
remedy for the management of facial
hyperpigmentation (dark spots). |