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
|
|
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
|
|
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 | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (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)
| 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (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. |