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CTRI Number  CTRI/2025/03/083674 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   The effect of viddha karma in the patients suffering with anxiety disorder. 
Scientific Title of Study   Randomized control trial to evaluate the effect of Viddha karma at Unmad Marma points in Generalized Anxiety Disorder cases 
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 Prachi Jain 
Designation  MD Scholar 
Affiliation  Institute of Medical Sciences 
Address  Department of Rachana Sharir, Faculty of Ayurveda IMS BHU Varanasi, Uttar Pradesh Pin- 221005 UTTAR PRADESH 221005 India Sir Sundarlal Hospital IMS BHU Varanasi, UTTAR PRADESH

Varanasi
UTTAR PRADESH
221005
India 
Phone  8004987919  
Fax    
Email  s.prachijain01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashutosh kumar Pathak 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences 
Address  Department of Rachana Sharir, Faculty of Ayurveda IMS BHU Varanasi, Uttar Pradesh Pin- 221005 UTTAR PRADESH 221005 India Sir Sundarlal Hospital IMS BHU Varanasi, UTTAR PRADESH

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415812548  
Fax    
Email  drpathakbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashutosh kumar Pathak 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences 
Address  Department of Rachana Sharir, Faculty of Ayurveda IMS BHU Varanasi, Uttar Pradesh Pin- 221005 UTTAR PRADESH 221005 India Sir Sundarlal Hospital IMS BHU Varanasi, UTTAR PRADESH

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415812548  
Fax    
Email  drpathakbhu@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychiatry IMS BHU 
Department of Rachana sharir FoA IMS BHU 
 
Primary Sponsor  
Name  Banaras Hindu University  
Address  Lanka Varanasi 221005 
Type of Sponsor  Research institution and hospital 
 
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 Prachi Jain  SSH BHU  Department of Psychiatry, Trauma center
Varanasi
UTTAR PRADESH 		 8004987919

s.prachijain01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Banaras Hindu University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F411||Generalized anxiety disorder. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: sushurta samhita, Procedure details: Identification of Marma point Sterile the area with the help of sanitizer in a cotton swab Puncture the point with the help of needle no 26 & half gauge needle Observe the point for 2 to 3 minutes for any excess letting of blood )
(1) Medicine Name: Paroxetine, Reference: Essentials of medical Pharmacology , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 25(mg), Frequency: od, Duration: 8 Weeks
2Intervention ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Sushurta samhita, Procedure details: Identification of Marma point Sterile the area with the help of sanitizer in a cotton swab Puncture the point with the help of needle no 26 & half gauge needle Observe the point for 2 to 3 minutes for any excess letting of blood )
3Comparator ArmProcedure-sirAvedhaH, सिरावेधः (Procedure Reference: Sushruta samhita, Procedure details: Identification of point other than marma points of unmad roga Sterile the area with the help of sanitizer in a cotton swab Puncture the point with the help of needle no 26 & half gauge needle Observe the point for 2 to 3 minutes, for any excess letting of blood )
(1) Medicine Name: vit. B12, Reference: essentials of medial pharmacology, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 25(mg), Frequency: od, Duration: 8 Weeks
4Comparator Arm (Non Ayurveda)-Drugparoxetine 25mg OD/AF
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Meeting the International Classification of Diseases (ICD-11) criteria for Generalized Anxiety Disorder with a diagnosis of anxiety validated by 2 scales
2 Willing to complete daily diary.
3 Willing to take the Viddha Therapy study for 60 days.
 
 
ExclusionCriteria 
Details  1 Age below 18 and 40 above years
2 Moderate to severe (25-30) degree cases in accordance with GAD-7 and HAMA score.
3 People living with psychiatric disorders in the spectrum of schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder substance-related disorders, and addictive disorders
4 Major medical illnesses under treatment such as Tuberculosis, AIDS, Malaria, Hypertension, Diabetes mellitus etc.
5 Pregnancy
6 Comorbid condition
7 Patient not willing to give his/her consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in symptoms of GAD   change in the GAD-7 and HAMA scoring after every week for eight week 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in scoring of following scales-
1 HAM-A Score
2 GAD-7
 		 60 days study with follow up every week 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   18/04/2025 
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="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  
160 cases of mild GAD will be included in this interventional study which will be randomly divided into 4 groups of 40 patients in each group. First group will be prescribed Standard treatment of anxiolytic drug Paroxetine along with standard viddha karma. Second group will be prescribed placebo with standard viddha karma. Third group will be prescribed with Standard treatment of anxiolytic drug Paroxetine along with viddha karma at placebo points. Fourth group will be placebo along with viddha karma at placebo points.
 
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