| CTRI Number |
CTRI/2024/12/077901 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to evaluate the effect of yastimadhu ksheera paka and kushmanda rasayana granules in artists with social phobia |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the tranquilizing effect of yastimadhu ksheera paka and kushmanda rasayana granules in artists with social phobia. |
| 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 Shantala S Bharbhari |
| Designation |
MD Scholar (Manasaroga) |
| Affiliation |
Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi |
| Address |
OPD3 Dept of Manasaroga Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8496060565 |
| Fax |
|
| Email |
shantalasb98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayendra G Bhat |
| Designation |
BAMS MD(Ayu) |
| Affiliation |
Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi |
| Address |
OPD3 Dept of Manasaroga Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448139919 |
| Fax |
|
| Email |
ayurvijay25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shantala S Bharbhari |
| Designation |
MD Scholar (Manasaroga) |
| Affiliation |
Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady Udupi |
| Address |
OPD3 Dept of Manasaroga Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8496060565 |
| Fax |
|
| Email |
shantalasb98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwar Ayurveda Pharmacy , Laxminaryana Nagar P.O. kuthpady Udupi, karnataka, India- 574118 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Shantala S Bharbhari |
Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady, Udupi |
OPD3 Dept of Manasaroga Shri Dharmashtala Manjunateshwara College of Ayurveda,Hospital and Research Centre, kuthpady, Udupi
Udupi
KARNATAKA |
08496060565
shantalasb98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F401||Social phobias. Ayurveda Condition: bhaya, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yastimadhu Ksheera Paka, Reference: Charaka Samhitha Chikithsa sthana; Karaprachatiya Rasayana; chapter 1.3, verse no 30, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kushmanda Rasayana Granules, Reference: The Ayurvedic Formulary of India (2nd ed.) part 1.Delhi: The controller of Publications Civil Lines; 2003; 36, Route: Oral, Dosage Form: Khanda /Granules, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Ksheera), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject fulfilling the DSM-5 Diagnostic criteria [for Social Phobia].
2.Artists – stage performers (Dancers, Singers, musician, debate, pick and speak, pick and act)
3.Age group: 18 -30yrs
4.Participants who are willing and able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from any other psychiatric and any organic disorders, lactating and pregnant Women will be excluded. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done by scoring subjective parameters by assessing on 0th, 14th and 28th day.
Severity Measure for Social Anxiety Disorder (Social Phobia). According to American psychiatric association.
Hamilton’s Anxiety Rating Scale.
WHO Quality of life Scale-Brief.
Manasika bhava scale
Scored parameters will be analysed statistically after the treatment. All the subjective parameters and scales will be assessed using Wilcoxon signed rank test within the groups and Mann-Whitney U test in between the groups.
|
Observation will be done on 0th , 14th and 28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
0th and 28th day |
|
|
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 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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
|
This is Raandomised open labelled parallel
group study comparing the safety and efficacy of the trial drug Group A
– Yastimadhu Ksheera Paka 1pala
before food morning Group B – Kushmanda Rasayana Granules 12grams
with milk on empty stomach early morning for 28 days in each group and
study will be conducted in Shri Dharmasthala Manjunatheshwara college of
Ayurveda Kuthpady Udupi, Karnataka,
India. The primary measures will be assessed through Severity Measure
for Social Anxiety Disorder (Social Phobia). According to American psychiatric
association, Hamilton’s
Anxiety Rating Scale, Manasika bhava scale. The secondary outcome majors
will be assessed based on the WHO Quality of life Scale-Brief hence the study is an effort to
prove the efficacy of Yastimadhu
Ksheera Paka and Kushmanda
Rasayana Granules in artists with social phobia. |