| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F320||Major depressive disorder, singleepisode, mild. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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 |