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CTRI Number  CTRI/2020/08/027234 [Registered on: 19/08/2020] Trial Registered Prospectively
Last Modified On: 12/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Local application and Internal]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to study the effect of BhruhatMarichyadi Taila and LaghuManjishtadi vati in Dark Patches over Facial skin  
Scientific Title of Study   “RANDOMISED CONTROLLED CLINICAL STUDY OF BRUHATMARICHAYADI TAILA AND LAGHU MANGISHTADI VATI IN VYANGA ROGA W.S.R.TO MELASMA & FACIAL MELANOSIS. 
Trial Acronym  RCBTLMV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sharmili Vijay Suryavanshi 
Designation  Ph D Scholar 
Affiliation  Government Ayurveda College and Hospital Nanded 
Address  Kayachikitsa Department Government Ayurveda College and Hospital Vazirabad Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9325565009  
Fax    
Email  drsharmili24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishwas Gogate 
Designation  Associate Professor 
Affiliation  Government Ayurveda College and Hospital Nanded 
Address  Kayachikitsa Department Government Ayurveda College and Hospital Vazirabad Nanded

Nanded
MAHARASHTRA
431601
India 
Phone  9422214311  
Fax    
Email  vishwas_eknath@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vishwas Gogate 
Designation  Associate Professor 
Affiliation  Government Ayurveda College and Hospital Nanded 
Address  Kayachikitsa Department Government Ayurveda College and Hospital Vazirabad Nanded


MAHARASHTRA
431601
India 
Phone  9422214311  
Fax    
Email  vishwas_eknath@yahoo.co.in  
 
Source of Monetary or Material Support  
Sharmili Suryavanshi Kayachikitsa Department Government Ayurved College and Hospital Vazirabad Nanded 
 
Primary Sponsor  
Name  Sharmili Vijay Suryavanshi 
Address  Government Ayurved college and Hospital Vazirabad Nanded 
Type of Sponsor  Other [Own Funded] 
 
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 Vishwas Gogate  Government Ayurved Hospital Nanded  OPD room no 18 Kayachikitsa Department Government Ayurveda Hospital Vazirabad Nanded
Nanded
MAHARASHTRA 		 9422214311

vishwas_eknath@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BhruhatMarichyaditaila LaghuManjishtadi vati  BhruhatMarichyaditaila (LA ) at night LaghuManjishtadi vati 500mg 2tab. BD Duration – 60 days  
Comparator Agent  Hydroquinone cream Cap.Antioxidant  Hydroquinone cream (LA) at night Cap.Antioxidant 1OD Duration – 60 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patients who are suffering from Vyanga roga for less than 4 years
2) Patients having symptoms of Vyanga Roga like Shyava ,Niruja, Tanu Mandal.
3) Subjects will be selected irrespective of socioeconomic conditions 
 
ExclusionCriteria 
Details  Subjects other than Vyanga roga like Nyaccha,Nilika ,Tilkalak & of Sahaj hetu
2) Subjects with Major Systemic Ilness like DM ,IHD , ARF ,CRF etc.
3) Subjects with major Endocrine disorders.
4) Subjects on Oral contraceptive pills / Hormonal therapy.
5) Pregnant & Lactating subjects. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Evaluate the Efficacy of Bruhatmarichyadi taila (local application ) and Laghu Manjishtadi Vati (Internally ) in management of Vyanga Roga by assessing reduction in the size of patches and the discoloration.
2) To study the relapse rate of Vyanga roga in both groups after cessation of treatment w.s.r. to Melasma & Facial melanosis  		 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
evaluate the Efficacy of Bruhatmarichyadi taila (local application ) and Laghu Manjishtadi Vati (Internally ) in the management Vyanga Roga w.s.r. to Melasma & Facial melanosis according to the chronicity of the disease   60 days 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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)   21/08/2020 
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   this study will be submitted in the form of thesis as a part of Ph D course to Maharashtra University Of Health Sciences. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a Randomised Controlled Clinical Study of BruhatMarichyadi taila and Laghu Manjishtadi Vati in Vyanga roga with Special Reference to Melasma and Facial Melanosis.This is a Research Studyis done  as a part of PhD course.In this study there will be a Trial group and a Control group with 65 patients each.Patients having signs and symptoms of Vyanga roga will be selected.Informed and written consent of the selected patients will be taken. Randomised Stratified sampling of the group will be done.Duration of study will be of 60 days with followup of the patients on day 0,5,30 and 60.Assessment will be done after the end of the treatment i.e.after 60days.  
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