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CTRI Number  CTRI/2017/12/010866 [Registered on: 13/12/2017] Trial Registered Prospectively
Last Modified On: 12/12/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Manasika Avasaada with Kushmanda ghrita either by Nasya or Pana 
Scientific Title of Study   A Comparative Clinical Study Of Kushmanda Ghrita as Nasya and Pana in the Management of Vishaada w.s.r. to Depression. 
Trial Acronym  KGNP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sabari Sengupta 
Designation  MD 2nd Year 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurved  
Address  PG Hospital OPD Room no 22 Department of Panchakarma IPGTand RA Gujarat Ayurved University Jamnagar
PG Hospital OPD Room no 22 Department of Panchakarma IPGTand RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9433823717  
Fax    
Email  sabari.sengupta68@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Anup Thakar 
Designation  HOD, Panchakarma Dept. 
Affiliation  Institute for Post GraduateTeaching and Research in Ayurveda 
Address  4th floor IPGT and RA Gujarat Ayurved University Jamnagar
4th floor IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Anup Thakar 
Designation  HOD, Panchakarma Dept. 
Affiliation  Institute for Post Graduate and Research in Ayurveda 
Address  4th floor IPGT and RA Gujarat Ayurved University Jamnagar
4th floor IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008  
 
Primary Sponsor  
Name  IPGT and RA 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat 361008 
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 
Sabari Sengupta  PG Hospital IPGT and RA  OPD Room no.-22, PG Hospital IPGT and RA Gujarat Ayurved University Jamnagar 361008
Jamnagar
GUJARAT 
9433823717

sabari.sengupta68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,Institute for Post Graduate Teaching and Research in Ayurveda   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patient diagnosed with Vishaada ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nasya with Kushmanda Ghrita   Group A In this group patients will be treated by Nasya with Kushmanda Ghrita 3ml Kushmanda Ghrita in each nostril on alternate 3 weeks 1st 3rd n 5th week total 21 days patient will be treated by Nasya 2nd 4th n 6th week will not be given Nasya  
Comparator Agent  Samana snena Pana with Kushmanda Ghrita   Group B Patient will be treated with sneha Pana with Kushmanda Ghrita 20 ml twice before intake of food when patient feels hungry with luke warm water for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The patient of Mild and Moderate Depressive disorder at least two (but less than five) of the following symptoms will be included in this study
(1 ) Marked loss of interest or pleasure in activities that are normally pleasurable
(2) Lack of emotional reactions to events or activities that normally produce an emotional response
(3) Waking in the morning 2 hours or more before the usual time
(4) Depression worse in the morning
(5) Objective evidence of marked psycho motor retardation or agitation (remarked on or reported by other people)
(6) Marked loss of appetite
(7) Weight loss (5% or more of body weight in the past month)
(8) Marked loss of libido
2. AGE 18 to 60 years of either sex
3. Chronicity less than 2 years
 
 
ExclusionCriteria 
Details  1.Age- Below 18 years and above 60 years
2.Anxiety obsessive compulsive disorders
3.Toxic causes like Alcohol ingestion and withdrawal
4.Organic diseases like some diseases of Gastrointestinal system for example
irritable bowel syndrome or Colitis
5.Myocardial Infarction
6.CNS diseases for example Alzeimer disease metabolic disorder and Endocrine disorders etc
7.Major Depressive Disorders
8.Patients superimposed with Schizophrenia schizophreniform disorders mania
Bipolar disorders as psychotic disorder not otherwise specified
9.Patients suffering from chronic drug abuse for example barbiturates etc
10.Mood incongruent delusions or hallucinations or marked loosening of associations
Patients suffering from chronic drug abuse 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
BECKs Depression Inventory
Hamilton Rating Scale of Depression
ICD-10 
45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improve life quality of patient  45 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   19/01/2018 
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   Not published yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The study comprises a Comparative Clinical study to evaluate the efficacy of Nasya  and Pana with Kushmanda ghrita in the management  of Vishaada with special reference to Depression. As Vishaada  mentioned in Ayurvedic classics as a Vataja Vyadhi  affects monobaha srotas mainly. So Kushmanda as Nasya n Pana   planned for Vishaada. 
 
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