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CTRI Number  CTRI/2025/07/091962 [Registered on: 29/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [curative]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on vachadi choorna and kushmandadi choorna in vishada depression 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of vachadi choorna and kushmandadi choorna in 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 Shilpa 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College And Hospital 
Address  Department of PG Studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College And Hospital Moodubidire DK karnataka
Alvas Ayurveda Medical College And Hospital Moodubidire DK Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9591421919  
Fax    
Email  78shilpabhat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raviprasad Hegde 
Designation  Associate Professor 
Affiliation  Alvas Ayurveda Medical College And Hospital 
Address  Department of PG Studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College And Hospital Moodubidire DK karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9448623599  
Fax    
Email  raviprasadhegde@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raviprasad Hegde 
Designation  Associate Professor 
Affiliation  Alvas Ayurveda Medical College And Hospital 
Address  Department of PG Studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College And Hospital Moodubidire DK karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9448623599  
Fax    
Email  raviprasadhegde@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College and Hospital DK moodubidire 574227 
 
Primary Sponsor  
Name  Dr Shilpa 
Address  Department of PG Studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College And Hospital Moodubidire DK Karnataka 574227 
Type of Sponsor  Other [Self] 
 
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 Shilpa  Alvas Ayurveda medical College  Department of PG Studies in Manovijnana Evam Manasaroga Alvas Ayurveda Medical College And Hospital Moodubidire DK Karnataka 574227
Dakshina Kannada
KARNATAKA 
09591421919

78shilpabhat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe Alvas Ayurveda Medical College  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: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kushmandadi Choorna, Reference: Bhavaprakasha chikitsa Sthana Unmada Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Vachadi choorna, Reference: Bhavaprakasha Chikitsa Sthana Unmada Chikitsa 22/33, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed as per the criteria for mild and moderate depression as per ICD-10.
Age between 16 to 60 years
 
 
ExclusionCriteria 
Details  Patients with other psychiatric disorders
Patients with systemic illness
Patients with major depression
Pregnant women/lactating women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of Kushmandadi Choorna and Vachadi Choorna on physical and psychological symptoms of Vishada  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Find a better alternative and cost effective treatment in the management of Vishada  45 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)   01/11/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

  NEED FOR THE STUDY

 

          Manas is the chief component responsible for perceiving good mental health which is a sign of good health mentioned in Sushruta Samhita.   Charaka has quoted ‘Vishado Rogavardhananam’ i.e. Vishada is the foremost factor in worsening the disease condition. The explanation of Vishada found in various references when compared to depression appear similar, so Vishada can be corelated with depression.  Depression is a state where person feel sad, hopeless, worthless, pessimistic and guilty

      According to WHO an estimated 3.8% of the population experience depression, including 5% of adults (4% among men and 6% among women), 5.7% of adults older than 60 years. Approximately 280 million people in the world have depression.There is Manobudhyadi Vibramsha  in Vishada as in Unmada hence Samanya Unmada Chikitsa can be used based on the understanding of the Dosha predominance.  Vachadi Choorna explained by Bhavaprakasha in Unmada Chikitsa, is Kapha Vatahara, Medhya, Vatanulomaka and Ojasya. As Vata is the controller of mind, normalcy of Vata is essential for Vatajananatmaja Vikara like Vishada.

        Kushmandadi Choorna is also explained by Bhavaprakasha in context of Unmada Chikitsa which is Kapha Vatahara, Balya and indicated in Manasa Vikara. Both Choorna in general contains Kusta Choorna which is Teekshna and Kapha Vatahara.

        As Vishada is a condition in which body and mind is affected and the qualities of both the Choorna can provide solution by attacking disturbed Vata and Kapha and improving the Buddhi and Medha helping in balance of psychological state of the individual.

        So this study is aimed to compare the efficacy of both Vachadi Choorna and Kushmandadi Choorna in Vishada.

  REVIEW OF LITERATURE

 

  •          Bhagavadgeeta mentioned about Vishada Lakshanas in Arjuna’s extended period of despondency during the war (cha.1/27-30).
  •         Acharya Charaka while describing Vataja Nanatmaja Vikara.(cha.su.20/11) has mentioned  Vishada is the disease caused by Vata.
  •         Vishado Rogavardhananam-While explaining Agrya Sangraha mentioned Vishada is the formost factor in worsening the disease condition. (cha.su 25/40).
  •        Acharya Charaka in Vimana Sthana 4/8 while explaining Anumanagamya Bhavas mentioned ‘Bhayam Vishadena;Dhairyam Avishadena’ means understanding the feeling of fear in a person by seeing his depression state or behaviour and also strength of one’s mind can be assessed by ability to face the adversities without fear.
  •       Acharya Sushruta mentioned Vishada as one among Manasa Roga(Su.su.1/33). Asiddhibhayat Vivideshu Karmasu Sadhoapravratti Vishada’.(Dalhana commentary on Su su 1/24)
  •       Asiddhibhayat Vivideshu Karmasu Sadhoapravritti Vishada’.(Dalhana commentary on Su.su.1/24)
  •       Vakkayachitta Avasadaha Vishadaha ( Su. Kalp. 3/21. Dalhana)
  •      Acharya Vagbhata explains that due to affliction of Dukha the person mind may get shield with Rajoguna or Tamoguna causing Vishada as - ‘Vishannatvam Dukkitatvam’ (A.H Arunadatta 2/17)
  •         Drug Review  - Bhavaprakasha Chikitsa Sthana Unmada Chikitsa -22/33       Vachadi Choorna –  Vacha, Kusta.      Kushmandadi Choorna -  Kushmanda Beeja , Kusta.

 AIMS AND OBJECTIVES OF THE STUDY

 

AIM

·       To find a better alternative and cost effective treatment in the management of Vishada.

OBJECTIVES

·       To know the effect of Kushmandadi Choorna and Vachadi Choorna on physical and psychological symptoms of Vishada.

·       To compare the efficacy of  Vachadi Choorna and Kushmandadi Choorna in the management of  Vishada

  

 
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