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CTRI Number  CTRI/2024/04/065341 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 30/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Therapeutic]  
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic medicine-siddartakadi yoga in depression 
Scientific Title of Study   A clinical study to evaluate the therapeutic effect of siddartakadi yoga in vishada w.s.r to 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 Soumya R korawar 
Designation  Pg scholar 
Affiliation  SDM AYURVEDA MEDICAL COLLEGE AND HOSPITAL UDUPI 
Address  Department of Kayachikitsa and Manasaroga, opd 3 SDM Ayurvedic Medical College and Hospital Kuthpady, Udupi.

Udupi
KARNATAKA
574118
India 
Phone  8147138778  
Fax    
Email  korwarsoumyar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dhaneshwari H A 
Designation  Assistant professor 
Affiliation  SDM AYURVEDA MEDICAL COLLEGE AND HOSPITAL UDUPI 
Address  Department of Kayachikitsa and Manasa roga SDM Ayurvedic Medical College and Hospital kuthpady, Udupi.

Udupi
KARNATAKA
574118
India 
Phone  9900554202  
Fax    
Email  drdhaneshwarisdm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Soumya R korawar 
Designation  Pg scholar 
Affiliation  SDM AYURVEDA MEDICAL COLLEGE AND HOSPITAL UDUPI 
Address  Department of Kayachikitsa and Manasaroga opd 3 SDM Ayurvedic Medical College and Hospital Kuthpady, Udupi.

Udupi
KARNATAKA
574118
India 
Phone  8147138778  
Fax    
Email  korwarsoumyar@gmail.com  
 
Source of Monetary or Material Support  
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hosptial, Kuthpady, Udupi. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Drsoumya korawar  Shri dharmasthala manjunatheshwara college of ayurveda and hospital kuthpady udupi  Department of manasaroga opd-3 SDM Ayurveda medical college and hospital kuthpady udupi
Udupi
KARNATAKA 		 8147138778

korwarsoumyar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICAL CLEARANCE COMMITTEE-HUMAN   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F320||Major depressive disorder, singleepisode, mild. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: SIDDARTAKADI YOGA , Reference: Yogaratnakara, Unmada Chikitsa , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukoshna jala ), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects having the Classical Symptoms of Vishada. The symptoms have been present during the 2 week period continuously and represent a change from previous functioning; at least one of the symptoms is either (1) Depressive Mood (2) Loss of Interest or Pleasure
2.Subjects who are willing to sign the informed consent form
3.Subjects in the age group from 18-60years of either gender 
 
ExclusionCriteria 
Details  1.Subjects having symptoms of Vataja-Pittaja Unmada, Bhutonmada, Apasmara, Atatvabhinivesha.
2.Subjects under Pregnancy condition, Lactating condition or below 18 years of age.
3.Subjects under any Allopathic Psychiatric Medications or other systemic illness. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changed in the signs and symptoms of Vishada/ Depression
changes in HAM-D(Hamilton Depression Rating Scale)
changes in the Measuring Quality of Life/The World Health Organization (WHOQOL) 		 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Objective
 		 2 weeks  
 
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 3 
Date of First Enrollment (India)   10/04/2024 
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="1"
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   This is a Clinical single group study of Siddartakadi Yoga in 30 patients diagnosed with Vishada/ Depression in the dose of 1TID with warm water as anupana for 30 days. The study will be conducted at Shri Dharmastala Manjunatheshwara Ayurveda Hospital Kuthpady Udupi Karnataka India. The primary outcome will be assessed based on HAM-D (Hamilton Depression Rating Scale), WHOQOL ( Measuring Quality of Life/ The World Health Organization) score before and after the treatment using subjective and objective parameters. Hence an effort has been planned through this clinical study to prove the efficacy of Siddartakdi Yoga in Vishada w.s.r. to Depression.  
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