| CTRI Number |
CTRI/2026/02/103952 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on participants with depression to compare the effect of Shirishadi yoga and saraswatha choorna interventions on the reduction of depression symptoms |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Shirishadi Yoga And Saraswata Choorna In Vishada (Depression) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NI |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Akash |
| Designation |
Post graduate schoar |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of Manovijnyana evam manasaroga 1st floor alvas ayuurveda medical college and hospital vidyagiri moodubidire karnataka
alvas ayuurveda medical college and hospital vidyagiri 13 national highway puttige padavu moodubidiri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8884143438 |
| Fax |
|
| Email |
ayurvedadrakash@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha K |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of Manovijnyana evam manasaroga 1st floor alvas ayuurveda medical college and hospital vidyagiri moodubidire karnataka
alvas ayuurveda medical college and hospital vidyagiri 13 national highway puttige padavu moodubidiri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8762309105 |
| Fax |
|
| Email |
dr.smithasuraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smitha K |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of Manovijnyana evam manasaroga 1st floor alvas ayuurveda medical college and hospital vidyagiri moodubidire karnataka
alvas ayuurveda medical college and hospital vidyagiri 13 national highway puttige padavu moodubidiri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8762309105 |
| Fax |
|
| Email |
dr.smithasuraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College And Hospital Vidyagiri Moodubidire Dakshina Kannada Karnataka India 574227 |
|
|
Primary Sponsor
|
| Name |
S Akash |
| Address |
Department of Manovijnyana evam manasaroga 1st floor alvas ayuurveda medical college and hospital vidyagiri moodubidire karnataka |
| 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 S Akash |
Alvas Ayurveda Medical College And Hospital |
Department of Manovijnyana evam manasaroga 1st floor room number 3 alvas ayuurveda medical college and hospital vidyagiri moodubidire karnataka
alvas ayuurveda medica college and hospital vidyagiri 13 national highway puttige padavu moodubidiri
Dakshina Kannada
KARNATAKA |
8884143438
ayurvedadrakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Alvas ayurveda college moodubidire karnatak |
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: VISHADAH/DINATA (KEVALAVATA), (2) ICD-10 Condition:F321||Major depressive disorder, singleepisode, moderate. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: saraswatha choorna, Reference: sahasra yoga choorna prakarana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -madhu and sarpi), Additional Information: -madhu and sarpi are given in unequal quantities | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shirishadi yoga, Reference: yogaratnakara unmada cikistha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -madhu and sarpi), Additional Information: -madhu and sarpi given in unequal quantities |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients wiling to participate and give informed written consent |
|
| ExclusionCriteria |
| Details |
1 severe depression and other psychiatric disorders
2 current use of anti psychiatric drugs or undergoing psychiatric therapy
3 pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of shirishadi yoga in comparison to saraswatha choorna in the management of vishada (depression) |
base line day,11 th day, 21 th day, 31 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
27/02/2026 |
| 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="6"
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
|
According to WHO 2022 report depression effects over 280 million worldwide making it one of most prevalent mental health conditions in most of the depression cases anti depressants and moos stabilizers are prescribed for management which have varying degree of drug interactions in such scenario there is need for efficient management in safer way there shirishadi yoga is proposed for clinical evaluation to assess it effectiveness |