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CTRI Number  CTRI/2019/08/020716 [Registered on: 14/08/2019] Trial Registered Prospectively
Last Modified On: 13/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A CLINICAL STUDY ON EFFECTIVENESS OF ATASI TAILA NASYA (LINUM USITATISSIMUM Linn) IN THE MANAGEMENT OF VISHADA (MILD TO MODERATE DEPRESSION) 
Scientific Title of Study   A Clinical Study on Effectiveness of Atasi taila Nasya (Linum usitatissimum Linn) in the Management of Vishada(Mild to Moderate Depression)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nithya P R 
Designation  Doctor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Post Graduate scholar, department of Manovigyana evum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9686345190  
Fax    
Email  pg17172@sdmcahhassan.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savitha HP 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan 
Address  Department of Manovigyana evum Manasaroga,OPD no 4, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  mr@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  Dr Nithya P R 
Designation  Doctor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Post Graduate scholar, department of Manovigyana evum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan


KARNATAKA
573201
India 
Phone  9686345190  
Fax    
Email  pg17172@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Dr Nithya P R, Post Graduate Scholar, Department of Manovigyanam Evum Manasaroga, OPD no 4, Sri Dharmsthala Manjunatheshwara College of Ayurveda and Hospital, B.M Road, Hassan 
 
Primary Sponsor  
Name  Dr Nithya P R 
Address  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, BM road, Hassan 
Type of Sponsor  Other [private individual] 
 
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 Nithya P R  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  OPD Number 4 Department of Manovigyanam Evum Manasroga
Hassan
KARNATAKA 
9686345190

pg17172@sdmcahhassan.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atasi Taila Nasya in the management of Vishada(mild to moderate depression)  Nasya karma in the patients of Vishada Poorva karma – Mukhabhyanga with Murchita taila and Sthanika Swedana. Pradhana karma – Nasya karma with Atasi beeja taila 6 drops to each nostril Paschath karma – dhoomapana with Haridra Varthi and monitoring the patient for 7 days. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed as per the criteria for mild and moderate depression as per ICD 10.
2. Age between 18 to 50 years.
3. Patients of either gender, irrespective of socioeconomic status.
4. Patients ready to sign informed consent form. 
 
ExclusionCriteria 
Details  1. Patients with other psychiatric disorders like Schizophrenia, Bipolar mood disorder and
substance abuse.
2. Patients with severe depressive disorder.
3. Pregnant women.
4. Patients with other systemic disorders like uncontrolled Hypertension, Diabetes mellitus,
Tuberculosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of Atasi beeja taila nasya in the management of Vishada (mild to moderate depression).  Assessment will be done on baseline, 3rd day and on 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  Assessment will be done on baseline, 3rd day and on 7th day 
 
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)   20/08/2019 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Vishada is a Vatananatmaja Vikara. The prime clinical features of Vishada are Sada (psychological fatigue) and Apravruthi (lack of motivation). These symptoms of Vishada resemble the disease depression clinically. According to WHO, depression is expected to become the second leading cause of disability worldwide by 2020. Around 350 million people worldwide suffer from depression. In India around 57 million people (18% of global estimate) suffer from depression. Around 65% youth between the age group 22-25 years shows early signs of depression. Severe depression can lead to suicidal tendency and is responsible for 850,000 deaths per year. 3 15% of the population of most developed countries suffers from severe depression. It remains a social stigma in terms of prevalence, suffering, dysfunction, morbidity and economic burden. If untreated it leads to a complications like Obesity, Diabetes, Alcohol or other drug addiction, Social phobia, Panic disorders, Family conflicts etc. Around 80% of depressed people are not currently having any treatment. Many research studies have found that depression is associated with the abnormality of omega-3 polyunsaturated fatty acids (PUFA) in serum and red blood cell membrane. Atasi is the richest source of α-linolenic acid (ALA) which can be endogenously converted into longer chain of omega-3 polyunsaturated fatty acids. Atasi beeja taila delivers greater amount of omega 3 compared to ground Atasi beeja and the Nasya conducted by using Atasi beeja taila is expected to have direct and instant effect on brain. Blood brain barrier being lipophilic in nature allows the passage of lipids and lipid soluble drugs across it. So here the study plan is to conduct Nasya with Atasi beeja taila in patients suffering from mild to moderate depression.
Nasya karma in the patients of Vishada
Poorva karma – Mukhabhyanga with Murchita taila and Sthanika Swedana.
Pradhana karma – Nasya karma with Atasi beeja taila .
Paschath karma – dhoomapana with Haridra Varthi and monitoring the patient for 7 days
 
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