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CTRI Number  CTRI/2025/02/080867 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Add-on effectiveness of viddhakarma in depression  
Scientific Title of Study   A clinical study on Add-on effectiveness of viddhakarma in the management of vishada(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 Hema B C 
Designation  Post graduate scholar  
Affiliation   
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan out patient department of Manasaroga, Room 08

Hassan
KARNATAKA
573201
India 
Phone  9342643060  
Fax    
Email  hemabc.rek@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Savitha H P  
Designation  Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  drsavithahp@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Savitha H P  
Designation  Professor  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla B M Road Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  drsavithahp@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, BM Road, Hassan, Karnataka, India, 573201 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  
Address  Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital, Thanniruhalla, BM Road, Hassan, Karnataka, India, 573201 
Type of Sponsor  Private medical college 
 
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 Hema B C   Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan   Department of Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan - 573201
Hassan
KARNATAKA 		 9342643060

hemabc.rek@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, 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:F39||Unspecified mood [affective] disorder. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Viddhakarma Pradhan Karma(Procedure Reference: Sushruta shareera 8/17, Procedure details: With the help of 26G x ½ inch disposable needle (0.45x13mm), a gentle prick of 2-4mm deep made at; Shankakeshanta sandhigata – At the hairline, above the depression, at the lateral end of the eyebrow. Apanga – At the depression, at the lateral end of the eyebrow. Lalata – On the forehead at 2/3rd of eyebrow, 1/3rd above laterally. Ura – On sternum, midpoint of right & left nipple.))
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects who fulfill the diagnostic criteria for vishada/depression.
Subjects irrespective of gender/religion/socioeconomic status.
Subjects who are willing to give the informed consent 
 
ExclusionCriteria 
Details  Subjects with other psychiatric disorders.
Subjects with H/o neurogenic shock for simple prick or trauma or sight of blood.
Subjects with skin infection at the place of puncture.
Subjects with uncontrolled diabetes.
5.Pregnantwome 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief of depression symptoms through viddhakarma by using Hamilton depression rating scale   After 7 days  
 
Secondary Outcome  
Outcome  TimePoints 
Remission of depression symptoms through viddhakarma   7 days  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   01/03/2025 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Depression is a common and serious mood disorder. Depression is linked with lack of interest, social withdrawal, dejection, reduced psychomotor activity, fondness to solitude and lack of enthusiasm. When compared to depression, vishada is discussed in various references and seem more applicable term to illustrate. Charaka has categorized it under vatananatmaja vikara. It is a condition that interferes with rajas, causing chanchalatva of manas, which is also chief quality of vata that results in apprehension of failure, reduced effort or action of body to function properly due to tamas resulting in srotorodha. As manovaha srotas is involved, ura(hridaya) and masthiska(shira) being abode for vishada, there by Viddhakarma, a para-surgical procedure that evacuates doshas from the nearest route, helps in clearing the doshas(srotoshuddhi) and helps to cope up with the condition. It is the modified and simplest type of siravyadha. With the help of 26G x ½ inch disposable needle (0.45x13mm), a gentle prick of 2-4mm deep made at the sites Shankakeshanta sandhigata, ura, apanga and lalata. It is done for 7 consecutive days. 
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