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
|
|
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
|
|
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 |