| CTRI Number |
CTRI/2026/01/102102 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Multani Mitti vs. Niacinamide Serum: A Comparative Study on Facial Sebum (Oil) Control |
|
Scientific Title of Study
|
Efficacy of a Multani Mitti (Fullers Earth) Face Pack versus 10 percent Niacinamide Serum on Facial Sebum Secretion: A Low-Cost Comparative Split-Face Pilot Study |
| Trial Acronym |
NOT APPLICABLE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khan Shama Yasmeen Zaheer Ahmad |
| Designation |
Student |
| Affiliation |
Z.V.M. Unani Medical College and Hospital, Pune |
| Address |
Z.V.M. Unani Medical College and Hospital, Gate No. 4, Azam Campus, K B Hidayatullah Road, 2390, Shankar Sheth Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
9307090441 |
| Fax |
|
| Email |
khanshamazaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayed Tauleha Tabassum Tayyeb Bukhari |
| Designation |
Assistant Professor |
| Affiliation |
Z.V.M. Unani Medical College and Hospital, Pune |
| Address |
Z.V.M. Unani Medical College and Hospital, Gate No. 4, Azam Campus, K B Hidayatullah Road, 2390, Shankar Sheth Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
7666349418 |
| Fax |
|
| Email |
taulehabukhari20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayed Tauleha Tabassum Tayyeb Bukhari |
| Designation |
Assistant Professor |
| Affiliation |
Z.V.M. Unani Medical College and Hospital, Pune |
| Address |
Z.V.M. Unani Medical College and Hospital, Gate No. 4, Azam Campus, K B Hidayatullah Road, 2390, Shankar Sheth Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA
411001
India |
| Phone |
7666349418 |
| Fax |
|
| Email |
taulehabukhari20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM), Ministry of Ayush, Government of India, 61-65, Institutional Area, Opposite D-Block, Janakpuri, New Delhi-110058, India. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM), Ministry of Ayush, Government of India |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 (India) |
| Type of Sponsor |
Research institution |
|
|
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 Sayed Tauleha Tabassum Tayyeb Bukhari |
Z.V.M. Unani Medical College and Hospital, Pue |
Gate No. 4, Azam Campus, K B Hidayatullah Road, 2390, Shankar Sheth Rd, Pune, Maharashtra 411001
Pune
MAHARASHTRA |
7666349418
taulehabukhari20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of M.C.E. Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The trial involves healthy individuals aged 18–35 with confirmed oily skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
10 percent Niacinamide Serum |
Comparator Product (C): A commercially available, water-based 10 percent Niacinamide serum (fragrance and oil-free)
10 percent Niacinamide Serum: Applied once daily on the assigned side of the face. |
| Intervention |
Multani Mitti (Fullers Earth) Face Pack |
Test Product (T): Multani Mitti Face Pack. Standardized preparation: 20 grams of pure, cosmetic-grade Multani Mitti powder will be mixed with a sufficient quantity of Arq-i-Gulab (Rose Water) to form a consistent, smooth paste immediately before application.
Frequency of Intervention:
Multani Mitti Face Pack: Applied twice weekly on the assigned side of the face, each application kept for 15 minutes, followed by rinsing with water.
Total Duration of Intervention:
The intervention for both study arms will be continued for a total duration of 4 weeks (28 days). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and female individuals between the age of 18 to 35 years.
2. Oily skin type confirmed at baseline using the blotting paper method, defined as a translucent oil spot of Grade 3 or More than Grade 3 on a 0-5 visual grading scale.
3. Individuals must show their willingness to provide written informed consent and comply with the study protocol which include a 1-week washout for every other facial topical treatment
|
|
| ExclusionCriteria |
| Details |
1. Known allergy to cosmetic products, clay or Niacinamide.
2. Active facial dermatoses (e.g., cystic acne, rosacea, atopic dermatitis).
3. Use of systemic or topical medications known to influence sebum production (e.g., oral/topical retinoids, hormonal agents) in the past 3 months.
4. Pregnancy or lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary (Sebum Secretion): Standardized blotting paper technique. A standard blotting paper (e.g., 5 cm x 5 cm) will be pressed firmly onto the forehead on each side for 10 seconds. The resulting translucent oil spot will be immediately graded by the blinded assessor against a validated 5-point visual scale (0=No spot, 1=Faint spot, 2=Moderate spot, 3=Large, distinct spot, 4=Saturated spot, 5=Oversaturated spot). The change in grade from Day 0 to Day 28 will be the primary outcome. |
Time points for outcome assessment in the present study are as follows:
Baseline (Day 0):
Assessment of facial sebum secretion using the blotting paper method and self-perceived oiliness using Visual Analogue Scale (VAS), prior to initiation of intervention.
End of Intervention – 4 Weeks (Day 28):
Re-assessment of facial sebum secretion and VAS scores to evaluate the effect of the interventions. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2026 |
| 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="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 single-blind, randomized split-face pilot study compares the efficacy of a traditional Multani Mitti face pack against a 10 percent Niacinamide serum in reducing facial sebum secretion over a four-week period. Ten participants with clinically confirmed oily skin apply Multani Mitti twice weekly to one assigned side of the face and Niacinamide serum once daily to the other. Success is measured primarily by a standardized blotting paper visual grading scale (0-5) to assess changes in oil spots, alongside secondary measures for local safety and self-perceived oiliness. |