| CTRI Number |
CTRI/2025/05/086683 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Eladigana Choorna on Reducing Hyperpigmentation in Postpartum Women |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFECT OF ELADIGANA CHOORNA ON CHLOASMA IN POSTPARTUM WOMEN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Chauhan |
| Designation |
PG2nd year |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Prasuti evem Stree roga Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O.. Kerala, India – 690 525
Kollam
KERALA
690525
India |
| Phone |
7505969063 |
| Fax |
|
| Email |
chauhanradhi1818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjaly MV |
| Designation |
Associate Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Prasuti evem Stree roga Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O.. Kerala, India – 690 525
Kollam
KERALA
690525
India |
| Phone |
9495114149 |
| Fax |
|
| Email |
dr.anjaly@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Radhika Chauhan |
| Designation |
PG2nd year |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Prasuti evem Stree roga Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O.. Kerala, India – 690 525
Kollam
KERALA
690525
India |
| Phone |
7505969063 |
| Fax |
|
| Email |
chauhanradhi1818@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RADHIKA |
| Address |
Amrita school of Ayurveda |
| Type of Sponsor |
Other [self] |
|
|
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 |
| radhika chauhan |
AMRITA SCHOOL OF AYURVEDA |
Department of Prasuti evem Stree roga Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O.. Kerala, India – 690 525
Kollam
KERALA |
7505969063
chauhanradhi1818@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AMRITA SCHOOL OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: KSHUDRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eradi Gana Choornam, Reference: Ashtanga Hridya , Sutrasthana 15/43-44, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum women with hyperpigmentation developed during pregnancy
Age more then 19 yrs.
Patients who clear the sensitivity test
Patient with MASI index score moreqthen 4
|
|
| ExclusionCriteria |
| Details |
Patient with any skin disease such as Psoriasis, Eczema, Skin cancer, wound in the hyper-pigmented area.
Patients who are allergic to the study drug.
Patient using any cosmetic products on the face
Patient not willing to stop the usage of face wash, moisturizer, or any other skin products during the course of treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the severity of chloasma in terms of darkness, area, and homogeneity assessed through MASI Index score and Improvement of skin color assessed through Color probe of DermaLab combo.
|
Day 1: Pre assessment screening and admission for the course of 2 weeks.
Day 15: post assessment and result
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 4 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
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
|
• Chloasma also known as Melasma or mask of pregnancy is a hyper pigmentary disorder. Most women get it on the face, neck, cheeks, chin, nose bridge, forehead and above the upper lip.Even though exact etiology of melasma is not identified, it can be due to sun exposure, hormonal changes during pregnancy and use of oral contraceptive pills.Prevalence of chloasma during pregnancy is 50% - 70% in 30 % of women it becomes permanent but it may disappear completely within 1 year followed by childbirth with treatment.The disfiguring appearance and easy visibility may result in reduced quality of life. Currently treatments are photoprotection, topical, oral therapies and procedures such as peelings, laser, and microneedling These treatments are not considered safe during pregnancy or postpartum as well as these treatments are not suitable for all types of skin. Acharya Haritha has explained vaivarnayta under astagarbhoupadrva so it can be correlated with chloasma . Patient who clears the sensitivity test for the study drug. Sensitivity test will be done on the recruitment day by applying Eladigana Choorna with lukewarm water over the neck area and observed for 20 minutes for any allergic reactions A sufficient quantity of Eladigana Choorna with lukewarm water will be mixed well and made into a paste.The patient will be asked to clean their face with Mudaga choorna and water.The Eladigana choorna which is made into the paste will be applied from medial to lateral direction over the hyperpigmented area. The lepa will be allowed to keep until it starts drying. After that, the patient will be asked to wash her face with lukewarm water and dry with a soft cotton cloth.
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