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CTRI Number  CTRI/2024/07/070250 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to study the effect of Nrupavallabha taila nasya followed by Raktachandanadi Udvartana in the management of Vyanga (Melasma) 
Scientific Title of Study   A Randomised Controlled Clinical Study to evaluate efficacy of Nrupavallabha taila Marsha Nasya followed by Raktachandanadi Udvartana in the management of Vyanga With Special Reference to Melasma. 
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 KAJAL PRAMODRAO DAHAKE 
Designation  PG Student  
Affiliation  R A Podar Medical (Ayu) College, Worli, Mumbai 
Address  R A Podar Medical (Ayu) College, Worli, Mumbai MAHARASHTRA 400018 India

Mumbai
MAHARASHTRA
400018
India 
Phone  9370870670  
Fax    
Email  dahakekajal123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Seema Chawardol 
Designation  MD & PhD Panchakarma HOD & Professor Panchakarma 
Affiliation  M A Podar Medical (Ayu) Hospital, Worli 
Address  Panchakarma OPD no. 7, M A Podar Medical (Ayu) Hospital, Worli, Mumbai MAHARASHTRA 400018 India

Mumbai
MAHARASHTRA
400018
India 
Phone  9881900560  
Fax    
Email  seemabahatkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR KAJAL PRAMODRAO DAHAKE 
Designation  PG Student  
Affiliation  R A Podar Medical (Ayu) College, Worli, Mumbai 
Address  R A Podar Medical (Ayu) College, Worli, Mumbai MAHARASHTRA 400018 India

Mumbai
MAHARASHTRA
400018
India 
Phone  9370870670  
Fax    
Email  dahakekajal123@gmail.com  
 
Source of Monetary or Material Support  
MA Podar Hospital, Worli, Mumbai, 400018 
 
Primary Sponsor  
Name  RA Podar Medical (Ayu) College, Worli, Mumbai  
Address  Dr Annie Besant Road, Worli, Mumbai, 400018 
Type of Sponsor  Government medical college 
 
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 KAJAL PRAMODRAO DAHAKE  M A Podar Hospital, Worli, Mumbai  Department of Panchakarma, M A Podar Hospital, Dr Annie Besant Road, Worli, Mumbai, 400018 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9370870670

dahakekajal123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, R A Podar Medical College (Ayu) And M.A. Podar Ayurvedic Hospital Worli, Mumbai, Maharashtra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L599||Disorder of the skin and subcutaneous tissue related to radiation, unspecified. Ayurveda Condition: VYANGAH, (3) ICD-10 Condition:L578||Other skin changes due to chronicexposure to nonionizing radiation. Ayurveda Condition: VYANGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-EkA~gga, एकांग sw (Procedure Reference: Ch.Su.5/86, Procedure details: Patient will be asked to lie in supine position on the table. Abhyanga with lukewarm tiltaila over face and neck region will be done for 10 min.)
(1) Medicine Name: Til taila, Reference: Ch.Su.13/12.........................................................................................................., Route: Topical, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-UShmasvedaH, ऊष्मस्वेदः (Procedure Reference: Su.Chi.32/13, Procedure details: Swedana to the respective areas will be carried out with the help of towel soaked in hot water)
3Intervention ArmProcedure-marSaH, मर्श (Procedure Reference: Ah. Su. 20/10, Procedure details: patient will be made to lie in supine position on the table with head level lower than body level (head low position). Using dropper Nrupavallabha taila will be dropped 8 – 8 drops (1drop will be taken as 0.23ml) in each nostrils. Then patient will be asked to take deep inhalation.)
(1) Medicine Name: Nrupavallabhataila , Reference: Chakradatta / Netraroga, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-kavalaH, कवलः (Procedure Reference: Su. Chi. 40/62, Procedure details: patient will be asked to spit out the medicine which reaches to throat. Then kavala with koshna jala will be done . Same procedure will be repeated for 7 days.)
(1) Medicine Name: Koshnajala, Reference: Not Applicable , Route: Oral, Dosage Form: Not Applicable, Dose: 200(ml), Frequency: od, Duration: 7 Days
5Intervention ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Ah. Su. 2/15, Procedure details: Patient will be asked to clean face with normal water, will take equal quantity of each churna and mix with required quantity of water, will be used to make paste up to semisolid consistency and will be applied on affected areas of face with gentle rub in an upward (pratiloma) or reverse direction as of the hairs over the skin. Before it dry ,wash will be advised with fresh water. Same procedure will be repeated for 14 days.)
(1) Medicine Name: Raktachandanadi, Reference: Ah. U. 32/17, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 14 Days
6Comparator ArmProcedure-EkA~gga, एकांग  (Procedure Reference: Ch. Su. 5/86, Procedure details: patient will be asked to lie in supine position on the table. Abhyanga with lukewarm tiltaila over face and neck region will be done for 10 min.)
(1) Medicine Name: Til taila, Reference: Ch. Su. 13/12, Route: Topical, Dosage Form: Taila, Dose: 10(drops), Frequency: od, Duration: 7 Days
7Comparator ArmProcedure-UShmasvedaH, ऊष्मस्वेदः (Procedure Reference: Su. Chi. 32/13, Procedure details: Swedana to the respective areas will be carried out with the help of towel soaked in hot water.)
(1) Medicine Name: Koshnajala, Reference: Not Applicable , Route: Topical, Dosage Form: Not Applicable, Dose: 200(ml), Frequency: od, Duration: 7 Days
8Comparator ArmProcedure-marSaH, मर्श (Procedure Reference: Ah. Su. 20/10, Procedure details: Patient will be made to lie in supine position on the table with head level lower than body level (head low position). Using dropper Kanaka taila will be dropped 8 – 8 drops (1drop will be taken as 0.23ml) in each nostrils. Then patient will be asked to take deep inhalation.)
(1) Medicine Name: Kanakataila, Reference: Bhaishajya Ratnavali 60/113, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
9Comparator ArmProcedure-kavalaH, कवलः (Procedure Reference: Su. Chi. 40/62, Procedure details: Patient will be asked to spit out the medicine which reaches to throat. Then kavala with koshna jala will be done. Same procedure will be repeated for 7 days.)
(1) Medicine Name: Koshnajala, Reference: Not Applicable , Route: Oral, Dosage Form: Not Applicable, Dose: 200(ml), Frequency: od, Duration: 7 Days
10Comparator ArmProcedure-udvartanam, उद्वर्तनम् (Procedure Reference: Ah. Su. 2/15, Procedure details: Patient will be asked to clean face with normal water, will take equal quantity of each churna and mix with required quantity of water, will be used to make paste up to semisolid consistency and will be applied on affected areas of face with gentle rub in an upward (pratiloma) or reverse direction as of the hairs over the skin. Before it dry ,wash will be advised with fresh water. Same procedure will be repeated for 14 days.)
(1) Medicine Name: Raktachandanadi, Reference: Ah. U. 32/17, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients fit for Nasya Karma according to Classics.
2. Patients having signs and symptoms of Vyanga like mandalakara, niruja, tanu, and shyav-varni mandala on face with 0.5 - 5 cm.
3. Patients having age group 20 - 60 yrs.
4. Patients of both genders.
5. Chronicity less than 5 years. 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women.
2. Post inflammatory hyperpigmentation, post acne hyperpigmentation.
3. Vyanga caused since birth like Nevus of ota.
4. Patients using depigmentation agents.
5. Patient having Acne vulgaris.
6. Patient having history of HIV /AIDS. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.There is reduction in MASI (Melasma Area Severity Index) Score indicating reduced Melasma.
2.There is reduction in Fitzpatrick scale score indicating reduced Color Melasma. 		 Day 1 and Day 36  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of no.of Mandala (circular lesions), Rukshata (Dryness), Size (diameter)  Day 1 and Day 36  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   N/A 
Date of First Enrollment (India)   16/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Flawless skin is a subject of socio-medico importance. Attitude towards flawless skin is increasing now a days, which also boost our confidence. Among all disorders, Vyanga is a type of Kshudra roga (group of skin disorder) explained by Acharya Sushruta in Lohit Twacha.
Among Panchakarma, Nasya is one indicated in Vyanga chikitsa by acharya Charaka and there are also local application like Lepa, Abhyanga, Udvartana etc.
According to Acharya Chakradutta Nrupavallabha taila and according to Acharya Vagbhat Raktachandanadi churna has vyanga nashak effect. Proper authentication and standardization of raw material and finished product will be done.

For an active control Kanakataila marsha nasya followed by Raktachandanadi Udvartana is used. The study is divided into 2 arms -

Intervention arm - Nrupavallabha taila marsha nasya followed by Raktachandanadi Udvartana

Comparator arm - Kanakataila marsha nasya followed by Raktachandanadi Udvartana

The study is single blind (participant blinded). Randomization will be done by using computer software.

32 sample size is taken from each arm, making it 64.

The volunteers will be asked for a marsha nasya with 8-8 drop of taila for 7 days then raktachandanadi udvartana for next 14 days. Vyanga will be assessed with the help of MASI ( Melasma Area Severity Index) score and color of vyanga will be measured with the help of Fitzpatrick scale.

After 7, 14 & 36 days follow up will be taken. The MASI score and Fitzpatrick scale is calculated and changes will be noted.

Statistical analysis and appropriate conclusion will be drawn.
 
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