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CTRI Number  CTRI/2022/11/047682 [Registered on: 25/11/2022] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic medication in the treatment of Major Depressive Disorder 
Scientific Title of Study   Efficacy Of Jatamansi Arka And Sarpagandhaghana Vati In Major Depressive Disorder - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavya Shree S 
Designation  PG Scholar 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi 
Address  Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  8197712713  
Fax    
Email  skavyashree13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Basavaraj R Tubaki 
Designation  Professor & Head of Department 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi 
Address  Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9448634660  
Fax    
Email  ayurbasavaraj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Basavaraj R Tubaki 
Designation  Professor & Head of Department 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi 
Address  Dept of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidhyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9448634660  
Fax    
Email  ayurbasavaraj@gmail.com  
 
Source of Monetary or Material Support  
Kahers Shri BMK Ayurveda Mahavidhyala Shahapur Belagavi 
 
Primary Sponsor  
Name  Dr Kavya Shree S 
Address  Kahers Shri BMK Ayurveda Mahavidhyala Shahapur Belagavi 
Type of Sponsor  Other [Self sponsored PG dissertation work] 
 
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 Kavya Shree S  KLE Shri BMK Ayurveda Hospital & Research Centre Shahapur Belagavi  KLE Shri BMK Ayurveda Hospital & Research Centre Shahapur Belagavi Department of Kayachikitsa OPD6 OPD7 OPD13 OPD14
Belgaum
KARNATAKA 
8197712713

skavyashree13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F322||Major depressive disorder, singleepisode, severe without psychotic features. Ayurveda Condition: KAPAJA-UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Jatamansi Arka, Reference: AFI-1,2:3, Arka prakasha 4/22, Route: Oral, Dosage Form: Arka, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -
(2) Medicine Name: Sarpagandhaghana Vati, Reference: AFI –3, 10:11 and Siddayoga sangraha –19, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -
2Comparator Arm (Non Ayurveda)-EscitalopramMedicine Name: Escitalopram, Dosage: 10 mg for 15 days and 20mg for next 45 days, Frequency: once a day at Bed time(OD) with water, Route: Oral, Total duration of time: 60 days, Additional Information: It is an SSRI group of drug . Advised in MDD  and GAD , Social anxiety disorder, OCD, PTSD. OD dose - with/without food . Starting dose of Escitalopram is 10mg. Compared to other antidepressant drug Escitalopram is having lower toxicity profile, despite of this it has its own adverse
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individuals between the age group of 20 to 60 years
2.Patients of Either sex
3.Subjects fulfilling the diagnostic criteria DSM 5 
 
ExclusionCriteria 
Details  1.Patients with Axis II disorder like personality disorders ​
2.Patients with other Axis I disorders like schizophrenia psychosis Anxiety disorders etc
3.Evidence of active suicidal ideation​
4.Depression with Psychotic symptoms​
5.Use of Psychotropics therapy drugs within the past period of 4 weeks​
6.Pregnant or lactating women​
7.Any other Chronic illness like Diabetes mellitus Cardiovascular diseases 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome of MDD on the basis of MADRS in 60 Days  Base line 15days 30days 45days 60days 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Secondary Outcome of MDD on the basis of CGI-Clinical Global Impression-Severity Index Global Improvement Efficacy Index, BHS-Becks Hopelessness Scale, WHO QOL BREF-World Health Organization Quality Of Life Bref, PSQI-Pittsberg Sleep Quality Index, UKU- UKU Side Effect Rating Scale, HAM-A-Hamilton Anxiety rating Scale in 60days  Baseline, 15days, 30days, 45days, 60days 
 
Target Sample Size
Modification(s)  
Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/03/2023 
Date of Study Completion (India) 06/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 06/06/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

According to  WHO’s the definition of health goes like this : Health is a state of complete physical, mental and social well being and not merely the absence of disease. And when mainly emphasizing on , Mental health refers to behavioral, cognitive and emotional well being. any changes in this well being can be considered as mental disorder ,which includes most commonly mood disorder, GAD, personality disorder, sleep disorders. Mental health is an integral part of our general health and well being and a basic human rights.

Depression being a very common disease is a major cause of suicidal death and disability. It commonly presents with symptoms like fatigue, worthlessness, guilt, loss of interest in daily activities,  afflicting the person’s mental, physical and social life. It is estimated that 3.8% of world population is afflicted with depression out of which 5.0% are among adults and 5.7% are among the adults more than 60yrs. In India 45.7 million people are suffering from this disorder out of  which 3.9% is contributed by female population and 2.7% by male population. People exposed to unfavourable circumstances like poverty, violence and inequality are at high risk of experiencing mental health conditions  which are also reported to be a risk factor for several secondary disorders. These people are prone to have recurrence of depression episodes. Conventional practice of oral medicines include SSRI & Anti-depressant group of drugs which are having adverse effects varying from simple dry mouth to many cardiovascular risks .

Similarly in the context of ayurveda, manas is made of  3 doshas i,e satva, rajas and tamas and alteration of these mano doshas causes manovikaras like atatvabinivesha, unmada, apasmara vyadhis, avasaada, vishada chittodwega - which are nothing but abnormal condition related to mental function.

In Ayurveda the above said condition can be correlated  with Kaphaja unmada [Mano vikara] .Classically Jatamansi arka and Sarpagandhaghana vati are being used to treat manovikaras. Having this idea as a whole, plan for further study is made for the better outcome in patients health.

 
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