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CTRI Number  CTRI/2024/12/078013 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 16/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Application of Jatiphala Lepa in the management of Vyanga with special reference to Melasma 
Scientific Title of Study   To evaluate the efficacy of Jatiphala Lepa on Vyanga w.s.r to Melasma-An experimental pilot study 
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 Pooja BA 
Designation  Associate Professor 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital Bengaluru 
Address  No. 2 OPD Panchakarma,Ground Floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru

Bangalore
KARNATAKA
560105
India 
Phone  9902209309  
Fax    
Email  drpoojaba@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pooja BA 
Designation  Associate Professor 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital Bengaluru 
Address  No. 2 OPD Panchakarma,Ground Floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru


KARNATAKA
560105
India 
Phone  9902209309  
Fax    
Email  drpoojaba@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja BA 
Designation  Associate Professor 
Affiliation  Sushrutha Ayurvedic Medical College and Hospital Bengaluru 
Address  No. 2 OPD Panchakarma,Ground Floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru


KARNATAKA
560105
India 
Phone  9902209309  
Fax    
Email  drpoojaba@gmail.com  
 
Source of Monetary or Material Support  
Sushrutha Ayurvedic Medical College and Hospital Pharmacy Prashanthi Kuteera Jigani Bengaluru Karnataka India 560106 
 
Primary Sponsor  
Name  Sushritha Ayurvedic Medical College and Hospital Pharmacy 
Address  Pharmacy Sushrutha Ayurvedic Medical College and Hospital,Prashanthi Kuteera Bengaluru 560105  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Dr Pooja BA  Associate Professor Department Of Panchakarma Sushrutha Ayurvedic Medical College and Hospital,Prashanthi Kuteera Bengaluru 560105 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pooja BA  Sushrutha Ayurveda Hospital OPD  No.2 OPD Panchakarma Ground FloorSushrutha Ayurvedic Medical College and Hospital,Prashanthi Kuteera Bengaluru 560105
Bangalore
KARNATAKA 		 9902209309

drpoojaba@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAMCH IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Yoga Ratnakara, Procedure details: The freshly prepared Jatiphala Lepa will be applied over the affected area every day for 28 days.Once the Lepa dries, will be washed with cold water. A semisolid paste is prepared with Jatiphala choorna and quantity sufficient freshly collected Go Ksheera. )
(1) Medicine Name: Jatiphala , Reference: Yoga Ratnakara, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Pigmentation caused by over exposure to sunlight
2. Due to hormonal changes, as an after effect of pregnancy and menopause
3. Having a positive family history
4. Aged Between 25 to 50 years
 
 
ExclusionCriteria 
Details  1. Pigmentation seen due to burns
2. Medication allergy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The effect of Jatiphala Lepa on Vyanga wsr to Melasma will be assessed using MASI score.
This will be helpful to see the drug effect and its imppact on patients health 		 Assessment will be done on baseline i.e, 0th day and 29th day. 
 
Secondary Outcome  
Outcome  TimePoints 
It heps in overcoming the emotional distress and impacting quality of life  60 days 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   16/01/2025 
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="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title:  To evaluate the efficacy of Jatiphala Lepa on Vyanga w.s.r to Melasma-An experimental pilot study.

 

Introduction :

  According to Ayurveda broadly the skin manifestations are explained under the heading of Kushta.But there are certain clinical conditions diagnosed based on the presentation over the skin only.One among them is Vyanga which have been incorporated under Kshudra Roga according to Acharya Sushruta.1

 The Lakshanas of Vyanga explained are Nirujam (painless), Tanukam  (not elevated from the skin surface), shyaavam(blackish colour) according to Yogaratnakara and Acharya Sushrutha 2,3.

 

 According to modern medicine it can be compared to Melasma. It is an acquired condition of symmetrical hyperpigmentation, mostly seen on the face. Though the exact etiology is unknown, multiple causes including sunlight exposure, hormonal changes, and family history has been proven. The incidence and prevalence of melasma is higher in females with a female to male ratio of approximately 4:1.

Melasma predominantly occurs in three major facial patterns. Centrofacial which includes forehead, nose, upper lip excluding the philtrum, cheeks, and chin where as Malar includes malar cheeks of face and Mandibular include jawline and chin.

A newer pattern has also been seen which is extra facial and occur on non facial body parts like neck, sternum,forearms, and upper extremities.

Treatment includes topical applications using corticosteroids,laser treatment and many more.These are aimed at various aspects of the pathogenesis of melasma including photodamage, inflammation,vascularity and pigmentation. But there are limitations in this treatment as it may damage healthy cells and also reoccurrence is observed. 5

In Ayurveda, Chikitsa for Vyanga includes Lepa i.e external application using different herbs and purificatory therapy .According to Yogaratnakara,among many lepas, Jatiphala Lepa has been specifically explained.3

 

 

 

Need for the study-

A research study on melasma is essential as it is affecting millions worldwide, causing emotional distress and impacting quality of life .With current treatments often have limited efficacy, significant side effects and high recurrence rates,hence study has been taken up with Jatiphala Lepa as it is cost effective and easily available.

 

Objective: To evaluate the efficacy of the Jatiphala Lepa in the management of Vyanga w.s.r to melasma.

 

Materials and Methods-

 

Source of data-

Minimum of 10 patients diagnosed with Vyanga fulfilling the study criteria will be randomly selected from OPD and IPD of Sushrutha Ayurvedic Medical College and Hospital,Bengaluru.

 

Drug source-

Jatiphala and Go Ksheera

Jatiphala will be procured and powdered from the Sushruta Ayurveda Pharmacy.

Go Ksheera will be freshly collected from  the Goshaala.4

 

Methodology-

The freshly prepared Jatiphala Lepa will be applied over the affected area every day for 28 days.Once the Lepa dries, will be washed with cold water.

A semisolid paste is prepared with Jatiphala choorna and quantity sufficient freshly collected Go Ksheera.

 

Diagnostic criteria-

Macular skin lesion with blackish discoloration over the face

 

Inclusion criteria:

1.      Pigmentation caused by over exposure to sunlight

2.      Due to hormonal changes, as an after effect of pregnancy and menopause

3.      Having a positive family history

 

Exclusion criteria:

1.      Pigmentation seen due to burns

2.      Medication allergy

 

Assessment criteria:-

 MASI score

MASI score( Melasma Area and Severity Index) is a scale used to measure the extent of facial hyperpigmentation. It is a numeric score calculated as an area weighted score of pigmentation located on forehead, chin, and both malar cheeks.5

 

Table showing the grading of the melasma area and severity index

Area(A)

0=No involvement;

1=<10% involvement;

2=11-29% involvement;

3=30-49% involvement;

4=50-69% involvement;

5=70-89% involvement;

6=90-100% involvement.

Darkness(D)

0=normal skin color;

1=barely visible hyperpigmentation;

2=mild hyperpigmentation;

3=moderate hyperpigmentation;

4=severe hyperpigmentation.

Homogenity(H)

0=normal without evidence of hyperpigmentation;

1=specks of involvement;

2=small patchy areas of involvement <1.5 cm diameter;

3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas.

Total score range from 0 to 48

 

Assesment will be done on  th day(before treatment) and 29 th day   (after the treatment )

 

 

References

1.Sushruta,Sushruta samhita,Nibandha sangraha commentary by dalhana,nidhana sthana,chapter 13,verse 45-46,chaukambha orientalia,Varanasi,reprint edition ,2019  ,pg no. 324.

2.Sushruta,Sushruta samhita,Nibandha sangraha commentary by dalhana,chikitsa sthana,chapter 20,verse 33-36,chaukambha orientalia,Varanasi,reprint edition,2019 ,pg no. 480.

3.Yogaratnakara samhita,vaidyaprabha commentary by Dr.Indradev Tripathi and Dr Daya Shankar Tripathi,Kshudraroga nidana chikitsa adyaya,verse 42-43,Chowkhamba Krishnadas Academy,Varanasi,2nd edition,2007,pg no.695.

4.Yogaratnakara samhita,vaidyaprabha commentary by Dr.Indradev Tripathi and Dr Daya Shankar Tripathi,Kshudraroga chikitsa adyaya,verse 132,Chowkhamba Krishnadas Academy,Varanasi,2nd  edition,2007,pg no.703.

5.Harrison’s et.al,Harrison’s Principles of Internal Medicine,A Blackiston publication,edition,pg no. 620.

 

 
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