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CTRI Number  CTRI/2024/03/063884 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Panchagavya Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression. 
Scientific Title of Study   Randomized Control Trials of Panchagavya Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression. 
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 Pramod Sakharam Mandalkar 
Designation  Ph D Scholar 
Affiliation  Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center, Astha 
Address  Department of Panchakarma Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali

Sangli
MAHARASHTRA
416301
India 
Phone  9604633832  
Fax    
Email  vdpramod31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pramod Sakharam Mandalkar 
Designation  Ph D Scholar 
Affiliation  Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center, Astha 
Address  Department of Panchakarma Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali

Sangli
MAHARASHTRA
416301
India 
Phone  9604633832  
Fax    
Email  vdpramod31@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alaknanda Kulkarni 
Designation  Ph D Guide 
Affiliation  Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center, Astha 
Address  Department of Panchakarma Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali

Sangli
MAHARASHTRA
416301
India 
Phone  9860359489  
Fax    
Email  vdalaknandakulkarni@gmail.com  
 
Source of Monetary or Material Support  
Department of Panchakarma Honorable Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Astha Tal Walwa Dist Sangali 
Department of Panchakarma SMBT Ayurved College and Hospital Dhamangaon Tal Igatpuri Dist Nashik 
GMP Certified Pharmacy 
 
Primary Sponsor  
Name  Dr Pramod Sakharam Mandalkar 
Address  Flat no 203 Blue Building Dream Citi Cooperative Housing Society Nashik Road Nashik 422006 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pramod Mandalkar  Honorable Annasaheb Dange Ayurved Medical College and Research Center Astha   OPD No 09 Department of Panchakarma
Sangli
MAHARASHTRA 
9604633832

vdpramod31@gmail.com 
Dr Pramod Mandalkar  SMBT Ayurved College and Hospital Dhamangaon Tal Igatpuri   OPD No 13 Department of Panchakarma
Nashik
MAHARASHTRA 
9604633832

vdpramod31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Annasaheb Dange Ayurved Medical College and Research Center Astha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G||Mental Health. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients diagnosed as per the criteria for Mild and Moderate depression as per ICD-10, Indicated for Nasya Karma procedure, Patient is not allowed other medications for depression during study period
 
 
ExclusionCriteria 
Details  Patients below age 18 and above 50 years, Contraindicated for Nasya Karma, Patients with other psychiatric disorders and major depressive disorder, Patients with Chronic illness like Cancer, Hypertension, Diabetes Mellitus and Thyroid Disorders, Patients with suicidal tendency or thoughts and Organic Mood disorders, Chronic drug abuse, Chronic Alcoholic
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of Panchagavya Ghrita Nasya and Hingwadi Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression.  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
To review of Vishada according to Ayurved and Modern aspects.
To review of Nasya Karma according to Ayurved and Modern aspects.
To study the Adverse Drug Reaction if observed.
To evaluate the probable mode of action of Panchagavya Ghrita Nasya. 
2 Years 
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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/ Phase 3 
Date of First Enrollment (India)   31/03/2024 
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 Yet Recruiting 
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  

The population-based study from India to report on depression shows that the prevalence of depression was 15.1%. India is home to an estimated 57 million people (18% of the global estimate) affected by depression. Considering the huge burden and impact of depression and its importance as public health concern in developing and developed world, the World Health Organization declared depression: Let’s Talk, as the theme of World Health day on April 07, 2017 and lead a yearlong campaign on depression domains. There is also a need to study the course of depressive disorders in India so as to determine the need and duration of continuation treatment. The present study Randomized Control Trials will be carried out with aim to evaluate the efficacy of Panchagavya Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression. For present study patients fulfilling the diagnostic criteria of Mild to Moderate Depression (ICD-10), between the age group of 18 yrs to 50 yrs with irrespective of Gender, religions, socioeconomic status etc. By using Sample size formula; Sample size found 57, so that 57 patients will be taken for study in each group. Total 114 numbers of patients will be selected and randomly divided into two groups, named as Group-A (Trial Group) and Group-B (Control Group) with Single Blind. Panchagavya Ghrita Nasya and Hingwadi Ghrita Nasya will be carried out in Group-A (Trial Group) patients and Group-B (Control Group) patients respectively. Trial and Control Drugs will be purchase from GMC certified pharmacy. Both drugs will be administered through nasal route with 3ml quantity in each nostril at morning hours continuous for 14 days. All SOP of Nasya Karma will be strictly followed during and after treatment. All the findings will be entered in Case Record Form (CRF) and for better understanding tabulation and graphical presentation will be done. Observations will be drawn on Before Treatment (0th day), During Treatment (At 7th day), After Treatment (At 14th day) and Weekly Follow-up after completion of treatment (At 21th day). Result of study will be calculated statistically with appropriate statistical method. Result will be drawn on basis of Criteria of assessment and Statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be draw strictly on basis of statistical Analysis and will be unbiased.

 
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