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
|
|
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
|
|
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. |