| CTRI Number |
CTRI/2025/01/079618 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Interventional Study Comparing the Effectiveness of Manjishtadi Taila and Manjishtadi Cream in the Management of hyperpigmentation (Melasma) |
|
Scientific Title of Study
|
A Comparative Randomized Clinical Trial of Manjishtadi Taila and Manjishtadi Cream in the Management of Vyanga with Special Reference to Melasma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana M R |
| Designation |
M.Sc (Ayu) Scholar |
| Affiliation |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Department of Saundarya Ayurveda, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
7025662917 |
| Fax |
|
| Email |
anjanamr9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krutika Chaudhary |
| Designation |
Assistant professor (Snr.) |
| Affiliation |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9408648068 |
| Fax |
|
| Email |
Vd.krutika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagriti Sharma |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Department of Saundarya Ayurveda, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461162206 |
| Fax |
|
| Email |
drjagritisharma573@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Deemed to be University, Jaipur, Jaipur, Rajasthan, India, 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda, Deemed to be University, Jaipur |
| Address |
Near Jorawar Singh Gate, Amer Road, Jaipur Rajasthan - 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Anjana M R |
National Institute of Ayurveda, Jaipur |
OPD Number - 19, National Institute of Ayurveda Hospital, Jorawar SIngh Gate, Amer Road, Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN |
7025662917
anjanamr9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi Taila, Reference: Chakradatta, Kshudraroga Chikitsaprakaranam, sloka 60-62., Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Apply Manjishtadi Taila on the affected area of face and massage for 5 minutes | | 2 | Comparator Arm (Non Ayurveda) | | - | Manjishtadi Cream | Cream is prepared from classical oil Manjishtadi taila and applied on the affected area of face, once daily for 2 months. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting clinical features of Vyanga - sudden onset of painless, circular, thin, blackish patches on face.
|
|
| ExclusionCriteria |
| Details |
Patients with known case of Carcinoma, Burns, Herpes, Eczema, Psoriasis, Measles, Chickenpox, Leukoderma and Leprosy.
Patients with known case of common systemic diseases like T.B. Diabetes, AIDS and Chickenpox.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in severity of pigmentation measured as per the assessment criteria - size, color, number of patches, associated symptoms like itching and burning sensation, mMASI score at baseline and after treatment.
|
2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Events-Monitoring and documenting any side effects or complications arising from treatment |
2 months |
|
|
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)
|
07/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Hyperpigmentation disorders are one of such rationale that
affects the normalcy of facial skin. Melasma is generally a clinical diagnosis
consisting of symmetric reticulated hyper melanosis on face. Vyanga is
one of the Kshudra roga that affect the second layer of Twak
which is characterised by the presence of Niruja (painless), Tanu
(light) & Shyava mandala over the face.
Manjishtadi Taila: Among the various
management methods of Vyanga, abhyanga is considered to be one of
the simple & effective procedure. According to Chakradatta, application
of Manjishtadi Taila helps to cure vyanga in 7 days.
Manjishtadi Cream: It is a modified form of a traditionally
recommended Ayurvedic formulation Manjishtadi Taila commonly used for
skin disorders. In today’s lifestyle, applying the oil makes the face greasy
and sticky, and massaging the oil is time consuming. Transforming the same
formulation into a cream will provide a more convenient, less time consuming
and user-friendly alternative as creams are non sticky and easily absorbable
form.
This study
is to compare the efficacy of Ayurvedic formulation, Manjishtadi Taila
and modern cosmetic product, Manjishtadi Cream in the management of Vyanga.
Research
Question: Whether there is any difference in clinical efficacy of Manjishtadi
Taila and Manjishtadi cream in the management of Vyanga?
Study
Design: The study consist of 2 groups with 15 patients in each group.
Group A:
Application of Manjishtadi Taila for 2 months.
Group B:
application of Manjishtadi Cream for 2 months.
Assessments:
Assessment will be done on the basis of scoring pattern for symptoms of Vyanga
and mMASI scoring for Melasma. |