| CTRI Number |
CTRI/2025/10/095562 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Desa Kumkumadi Ghrita in healthy participants suffering from dark spots on face |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of Desa Kumkumadi Ghrita 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/DESA/2025/1, Version 1.0, 14th August 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand M Pawar |
| Designation |
Principal and Administrative Officer |
| Affiliation |
Late B.V. Kale & Manjara Ayurved Medical College & Hospital |
| Address |
Department of Panchakarma, OPD no.-10, Ground floor
Late B.V. Kale & Manjara Ayurved Medical College & Hospital, Gandhi Maidan, Gandhi Market, behind Bus Stand, Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
9405647469 |
| Fax |
|
| Email |
vd_ananda@rediffmail.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
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
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| HOUSE OF ADITI PRIVATE LIMITED
Unit No. 4, Peninsula Chambers,
Peninsula Corporate Park, G. K. Marg,
Lower Parel Mumbai – 400013.
|
|
|
Primary Sponsor
|
| Name |
HOUSE OF ADITI PRIVATE LIMITED |
| Address |
Unit No. 4, Peninsula Chambers, Peninsula Corporate Park, G. K. Marg, Lower Parel Mumbai – 400013.
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
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 Anand M Pawar |
Late B.V. Kale & Manjara Ayurved Medical College & Hospital |
Department of Panchakarma, OPD no.-10, Ground floor
Late B.V. Kale & Manjara Ayurved Medical College & Hospital, Gandhi Maidan, Gandhi Market, behind Bus Stand, Latur, Maharashtra -413512
Latur
MAHARASHTRA |
9405647469
vd_ananda@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Late B.V. Kale & Manjara Ayurved Medical College & Hospital |
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: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kumkumadi Ghrita, Reference: Chakradatta, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Desa Kumkumadi Ghrita on face and massage for 1 minute once daily for a period of 30 days. Subjects will be asked to retain Desa Kumkumadi Ghrita on face for at least 1 hour then wash face with warm water | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
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, facial solar lentigines, melasma, post inflammatory hyperpigmentation, periorbital hyperpigmentation, post acne dark spots.
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
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, 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 Desa Kumkumadi Ghrit
8. Dosage and Treatment Duration Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in facial hyperpigmentation spot |
Baseline visit (day 0), day 15 and end of study visit (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 (periorbital and perioral)
7. Difference in number of comedones (blackheads and whiteheads) on the face
8. Assessment of ability of Desa Kumkumadi Ghrita to absorb into the skin
9. Assessment of oily or greasy appearance of skin after application of Ghrita
10. Assessment of feeling of Ghrita on skin
11. Global assessment for overall change by participants and by physician
12. Assessment of post treatment tolerability of study drug by participants and physician.
13. Assessment of adverse events, adverse drug reactions including vitals
|
Baseline visit (day 0), day 15 and end of study visit (Day 30) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
14/10/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a clinical
study on Desa Kumkumadi Ghrita in participants suffering from Facial
hyperpigmentation. The study will be conducted at one center in India. Subjects
will be asked to apply Desa Kumkumadi Ghrita on face and massage for 1 minute
once daily for a period of 30 days. Subjects will be asked to retain Desa
Kumkumadi Ghrita on face for at least 1 hour then wash face with warm water.
The primary objective of the study will be to assess change in facial
hyperpigmentation spot. The secondary objectives of the study will be to assess
changes in photographic evaluation of Facial hyperpigmentation spot, skin
lightening effect, skin glow, assessment of 24 hours skin patch test, facial
cutaneous moisturization, facial wrinkles (periorbital and perioral),
difference in number of comedones (blackheads and whiteheads) on the face,
ability of Desa Kumkumadi Ghrita to absorb into the skin, oily or greasy
appearance of skin after application of Ghrita, feeling of Ghrita on skin,
global assessment of overall change by participants and by physician, post treatment tolerability of study drug by
participants and physician and adverse events, adverse drug reactions including
vitals on baseline visit (day 0), day 15 and end of study visit (Day 30) |