| CTRI Number |
CTRI/2025/02/081475 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of Kushmanda Rasayana (a medicated polyherbal preparation in the form of avaleha) on student stress |
|
Scientific Title of Study
|
An interventional study to evaluate the efficacy of kushmanda rasayana on student stress |
| 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 Bhavani S Biradar |
| Designation |
PG Scholar |
| Affiliation |
Alvas ayurveda medical college vidyagiri, moodabidire |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moobubidire, Dakshina Kannada district, Karnataka 574227 India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moobubidire, Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9353305353 |
| Fax |
|
| Email |
bhavanibiradar50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K N Rajashekhar |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College Moodabidire |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hopital Vidyagiri, Moodabidire, Dakshina Kannada district
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481511292 |
| Fax |
|
| Email |
drknraamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavani S Biradar |
| Designation |
PG Scholar |
| Affiliation |
Alvas ayurveda medical college vidyagiri, moodabidire |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire. Dakshina Kannada district, Karnataka 574227 India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire. Dakshina Kannada district, Karnataka 574227 India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9353305353 |
| Fax |
|
| Email |
bhavanibiradar50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PG studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri Moodubidire Dakshina Kannada Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr BHAVANI S BIRADAR |
| Address |
PG Scholar Department Of PG Studies In Kriya Shareera Alvas Ayurveda Medical College, Vidyagiri Moodabidire Dakshina Kannada District, Karnataka |
| Type of Sponsor |
Other [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 BHAVANI S BIRADAR |
Alvas Ayurveda medical College |
Department of Kriya shareera 4th floor Alvas ayurveda medical college and hospital Moodabidire
Dakshina Kannada
KARNATAKA |
9353305353
bhavanibiradar50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Alvas Ayurveda medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects diagnosed with mild to moderate anxiety/stress |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushmanda Rasayana, Reference: Sahasrayoga 7th Adhyaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: hot water), Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
individual with age group of 16-25 year students irrespective of gender, educational status, socio economic status, marital status and religion. Subjects diagnosed with mild and moderate anxiety/stress. Stress present since 1 year |
|
| ExclusionCriteria |
| Details |
individual who are having any psychiatric disorders
individual who are suffering from sever anxiety
individual with any systemic illness
Any other conditions which directly or indirectly interferes this study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in stress, To evaluate the effect of Kushmanda Rasayana on Student stress |
30 days of treatment, follow up on 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/03/2025 |
| 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="0"
Months="1"
Days="15" |
|
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
|
It is a clinical study to evaluate the efficacy of kushmanda rasayana in the form of Avaleha on stress in students. medicine will be given for 30 days and follow up on 15th day, total 45 days. total 30 subjects, that will be conducted in the department of kriya shareera Alvas ayurveda medical college vidhyagiri moodabidire. |