| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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|
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, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Escitalopram | Medicine 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 |
|
|
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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. |