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CTRI Number  CTRI/2022/07/044493 [Registered on: 29/07/2022] Trial Registered Prospectively
Last Modified On: 24/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Melasma (Brownish Hyperpigmentation) through ayurvedic line of managemnet 
Scientific Title of Study   A comparative clinical trial on the effect of Balaadi saksheera siddha sarpi nasya and Jalaukavacharana in the management of Pittaja vyanga 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhaskar B 
Designation  2nd Year MD [Ayu] Scholar 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Address  Department Of Post Graduate Studies In Panchakarma Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center Koppal Karnataka 583231 India

Koppal
KARNATAKA
583231
India 
Phone  7829442579  
Fax    
Email  bhaskarb116677@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjunath P Akki 
Designation  Professor 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Address  Department Of Post Graduate Studies In Panchakarma Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center Koppal Koppal Karnataka 583231 India

Koppal
KARNATAKA
583231
India 
Phone  8123044125  
Fax    
Email  drmanju78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjunath P Akki 
Designation  Professor 
Affiliation  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Address  Department Of Post Graduate Studies In Panchakarma Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center Koppal Koppal Karnataka 583231 India

Koppal
KARNATAKA
583231
India 
Phone  8123044125  
Fax    
Email  drmanju78@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal 
 
Primary Sponsor  
Name  Department Of Panchakarma 
Address  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center 
Type of Sponsor  Research institution and hospital 
 
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 Bhaskar B  Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies And Research Center  Department Of Panchakarma Room No 01 Koppal Karnataka
Koppal
KARNATAKA 
7829442579

bhaskarb116677@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: Prof. JyotirMitra, AshtangaSangraha, Shashilekha commentary by Indu, Uttaratantram, 37/21, Varanasi, Chowkhamba Sanskrit Series Office, print 2012,PageNo-822., Procedure details: 2 sittings of Jalaukavacharana on 1st and 14th day)
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Prof. JyotirMitra, AshtangaSangraha, Shashilekha commentary by Indu, Uttaratantram, 37/21, Varanasi, Chowkhamba Sanskrit Series Office, print 2012,PageNo-822., Procedure details: 2 weeks Nasya karma with Balaadi Saksheera siddha Sarpi 8 bindu matra )
(1) Medicine Name: Balaadi Saksheera siddha Sarpi, Reference: Prof. JyotirMitra, AshtangaSangraha, Shashilekha commentary by Indu, Uttaratantram, 37/21, Varanasi, Chowkhamba Sanskrit Series Office, print 2012,PageNo-822., Route: Nasal, Dosage Form: Ghrita, Dose: 08(drops), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients fulfilling the diagnostic criteria of PittajaVyanga, Well demarcated Macules to Patches will be selected irrespective of sex.
2.Patients between the age group of 16-60 years.
3.Patients fit for Nasya and Jalaukavacharana.
4.Patients with duration of Pittaja Vyanga less than 3years
 
 
ExclusionCriteria 
Details  1.Patients with systemic disorders which interfere with the course of the treatment.
2.Pregnant women, and lactating mother, Women on oral contraceptives.
3.Hyper pigmentation caused by tumor like malignant melanoma.
4.Vyanga due to any Trauma.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO REDUCE THE HYPERPIGMENTATION  28days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve overall skin health.  4 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   03/08/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The skin would reflect any unhealthy state of the physique or psyche, as beauty manifests through the appearance of the complexion of the skin. The colour of the skin is important biologically, cosmetically, and socially. Skin diseases though afflict bodily but give a lot of psychological disturbances. In India, lots of money is spent on cosmetic products which duly fail to give a satisfactory results. But Ayurveda relatively proved to be efficacious in the treatment of skin diseases. It provides an effective, safe and economically cheaper methods of treatment.

Vyangais described under Kshudra roga1. It is a condition where the aggravated Vata Pitta gets localized in the Mukhapradesha causing an important sign of Neeruja, Tanu, Shyaava, varnayukta mandala in general2, where as in PittajaVyangaTaamrantam and Aneelam signs are mentioned3. This condition of Vyanga can be correlated with Melasma. Since Melasmais common acquired symmetric hypermelanosis characterized by irregular light brown to gray brown Macules involving sun-exposed areas. There is a predilection for the cheeks, forehead, upper lips, nose and chin area4.

Its known that Melasma occurs in all ethnic groups, However, epidemollogical studies have reported higher prevalence among more pigmented phenotypes such as East Asians, Indians, Koreans and Chineese5. The reported prevalence of Melasma in a tertiary care  hospitalin India was found to be 20.5% in men6. Melasmais more common in females than in males. In present era, people are more concerned towards aesthetic problems. Since Vyangais one such cosmetic condition, which not only hinders the beauty and physical approach of an individual but also leads to hindrance of one’s self confidence and causes depression. Since modern aesthetic treatment are costly and doesn’t provide complete cure. Need for better intervention through ayurveda becomenecessary.

                          Among the Panchakarma, Acharya’s have mentioned about Nasya karma, Rudhiravasechana, Aalepa and many treatment modality in Pittaja Vyanga7. Jalaukavacharanais best in conditions like PittajaVyanga also, due to the predominance of Pitta dushti by virtue of its habitat8. Since Jalaukavacharana is a para-surgical procedure it can be performed in Paramasukumara9. Though there are references regarding both Nasya and Rudhiravasechana for the management of Vyanga many of the research works were carried out mainly on Nasya, Hence Rudhiravasechana is the unique procedure that needs to be brought to the limelight. So an approach towards treating PittajaVyanga, through Nasya with Balaadi Saksheera Siddha Sarpi7 and Jalaukavacharanais planned for the study. 
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