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CTRI Number  CTRI/2023/09/058009 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 12/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Lepa ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial to Study the Effect of Wet and Dry Dadima Fruit Peel In Melasma 
Scientific Title of Study   Pharmacognostical and Clinico-Comparative Study to Evaluate the Efficacy of Ardra and Shushka Dadima (Punica Granatum Linn) Phala Twak Lepa in Vyanga 
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 Safiya Falak 
Designation  PG Scholar  
Affiliation  Sri Siddharoodha Charitable Hospital  
Address  Dept Of Dravya Guna OPD Room 4 (Kayachikitsa), OPD Room 05 (Panchakarma), OPD Room 6 (Prasuti Tantra) N K Jabshetty Ayurvedic Medical College and PG Centre Gumpa Bidar
Shri Siddharudh Math Gumpa Bidar
Bidar
KARNATAKA
585403
India 
Phone  9513277277  
Fax    
Email  drsafiyafalak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhulappa M  
Designation  Professor and HOD  
Affiliation  Sri Siddharudha Charitable Hospital  
Address  Dept of Dravya Guna OPD Room 05, N K Jabshetty Ayurvedic Medical College and PG Centre Gumpa Bidar
Shri Siddharudh Math Gumpa Bidar
Bidar
KARNATAKA
585403
India 
Phone  9916268631  
Fax    
Email  mdhulappa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Safiya Falak 
Designation  PG Scholar 
Affiliation  Sri Siddharudha Charitable Hospital  
Address  Dept of Dravya Guna, OPD Room 05, OPD Room 04, OPD Room 06 N K Jabshetty Ayurvedic Medical College and PG Centre Gumpa Bidar
Shri Siddharudh Math Gumpa Bidar
Bidar
KARNATAKA
585403
India 
Phone  9513277277  
Fax    
Email  drsafiyafalak@gmail.com  
 
Source of Monetary or Material Support  
N K Jabshetty Ayurvedic Medical college and PG Centre, Sri Siddharudh Charitable Hospital Gumpa Bidar  
 
Primary Sponsor  
Name  Dr Safiya Falak 
Address  N K jabshetty Ayurvedic Medical college and PG Centre Shri Siddharudh Math Gumpa Bidar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Safiya Falak  Sri Siddharudh Charitable Hospital   Dept of Dravya Guna OPD Room 05, OPD Room 04 and OPD Room 06
Bidar
KARNATAKA 
9513277277

drsafiyafalak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of N K Jabshetty Ayurvedic Medical College and PG Centre Bidar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Ardra Dadima phala twak , Reference: Asthanga sangraha , Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: NA
2Comparator ArmDrugClassical(1) Medicine Name: Shushka Dadima phala twak, Reference: Asthanga Sangraha , Route: Topical, Dosage Form: Lepa Churna, Dose: 50(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: NA
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.18-50 years of subjects, irrespective of gender.
2.Acute cases of melasma (<1year).
3.Area-Nose, cheeks, upperchin, forehead.
 
 
ExclusionCriteria 
Details  1. Chronic cases more than >2year.
2. Associatedwithanyserioussystemicdisorder.
3. Historyofallergytotopicalapplications.
4. Pregnancy induced melasma.
5. SkinCancer.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in
a.Shyavavarnata
b.Kandu
c.Number of patches
d.Pigmentation
 
0 Day, 15 Day, 30 Day and 45 Day
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in MSI Score and colour and compexion   0 Day, 15 Day, 30 Day and 45 Day
 
 
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)   02/10/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
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  

 BRIEF RESUME OF THE INTENDED WORK:

 NEED FOR THE STUDY

            Beauty is a subject of socio-medical importance since ancient times. As time passes the importance and demand for beautification also increased. But, few facial disorders are still a problem which damages beauty, among themmelasma is one.

            Melasma is a chronic acquired hypermelanosis of skin characterized by irregular brown patches symmetrically distributed on sun exposed area particularly on face1. Due to its frequent facial involvement, the disease has an impact on quality of life of a person and is a cause of psychologicaldistress.

             The melasma affects both gender, but a clear female predominance was observed. The prevalence rate of melasma varies from 1.5% to 33.3%, depending on the population2. It’s pathology is not yet completely understood, although there are some known factors such as excessive sun exposure, inflammatory process of skindue to irritants, pregnancy, use of oral contraceptive pills, cosmetics, steroids, etc are responsible for over production of melanin pigment in skin causing melasma3.

            In contemporary science most effectivetherapy for melasma includes combination of topical agents and oral medications, such as hydroquinone, tretinoin and tranexamic acid, etc4.

In Ayurveda melasma may be compared with vyanga, which is caused by the vitiation of vata and pitta dosha, and is characterized by neeruja, tanu, shyava varnayukta mandala on mukha pradesha5.

In Ayurveda, different treatment modalities are mentioned for the management of vyanga such as raktamokshana, varnyakaradravyalepa etc. And there are many varnyadravyas are mentioned for vyanga such as Manjishtha, Arjuna, Lodhra, Dadima, etc6.

            Among these Dadima (Punica granatum Linn) phala twak is one, which is non-controversial, easily available and cost-effective, posses the properties like madhura, kashaya, amla rasa, laghu,snigdhaguna, anushnaveerya, madhuravipaka and act as varnyakara, grahi, hridya, etc7.

            According to classics, the Dadima phala twak is advised to be used in Ardra (wet) form along with goat’s milk in the management of vyanga8. But the fruit is not available in all seasons. Hence, an attempt will be made to evaluate and compare the efficacy of both Ardra (wet) and Shushka (dry) Dadima phala twak lepa in the vyanga by clinical trial. 

OBJECTIVES OF THE STUDY:

1.      To study pharmacognostical and phytochemical characters of Ardra and Shushka Dadima phala twak (Punica granatum Linn).

2.      To evaluate and compare the efficacy of Ardra andSushkaDadimaphalatwaklepa in vyanga.Research Design

1.      Study Design: Pharmacognostical and open labelled two armed clinical trial.

2.      Sample Size: 30 subjects of vyanga (melasma).

3.      Selection Criteria: Diagnosed subjects of vyanga will be selected on the basisof simple randomized sampling procedure by preparing special case proforma.

4.      Duration: 30 days.

5.      Grouping: 30 subjects will be allocated into two groups, consisting of 20 subjectsin each group.

Group-I: Trial group will be treated with Ardra Dadima Phala twak lepa.

Group-II: Trial group will be treated with Shushka Damida Phala twak lepa.

6. PARAMETERS:

1) SUBJECTIVE CRITERIA:

a.       Shyavavarnata

b.      Kandu

2) OBJECTIVE CRITERIA:

a.       Number of patches

b.      Area of pigmentation

INCLUSIONCRITERIA:

1.      18-50 years of subjects, irrespective of gender.

2.      Acute cases of melasma (<1year).

3.      Area-Nose, cheeks, upperchin, forehead.

EXCLUSIONCRITERIA:

1.      Chronic cases more than >2year.

2.      Associatedwithanyserioussystemicdisorder.

3.      Historyofallergytotopicalapplications.

4.      Pregnancy induced melasma.

5.      SkinCancer.

7. INTERVENTION CHART:

Sl. No

Group

Test Drug

Part Used

Route of Administration and Form

No. of Patients

Dose

Base

Duration

1

I

ArdaDadimaphala

Twak

Lepa

15

Q.S.

Goat’s Milk

30 days

2

II

ShushkaDadimaphala

Twak

Lepa

15

Q.S.

Goat’s Milk

30 days

3) MSI Score:Melasma Severity Index

Formula: MSI = 0.4(a×p2)l+0.4(a×p2)r+0.2(a×p2)n or MSI = a×p2

Where; a = area of involvement, p = severity of pigmentation, l = left face, r = right face, n = nose


 
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