| CTRI Number |
CTRI/2025/04/084876 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate and compare the effect of Tulsi capsules alone and along with guided imagery meditation in professional students suffering from Adjustment disorder |
|
Scientific Title of Study
|
An open label comparative clinical study to evaluate the enhanced effect of Guided imagery meditation with Tulsi (Ocimum sanctum Linn) capsule on professional students in Chittodvega w.s.r to Adjustment disorder |
| Trial Acronym |
GIM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayesha Afnan |
| Designation |
MD Scholar (Manasaroga) |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research centre, Kuthpady |
| Address |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research centre, Kuthpady
Udupi
KARNATAKA
574118
India |
| Phone |
9591438360 |
| Fax |
|
| Email |
afnanaps007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayendra G Bhat |
| Designation |
BAMS MD(Ayu) |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research centre, Kuthpady |
| Address |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research centre, Kuthpady
Udupi
KARNATAKA
574118
India |
| Phone |
9448139919 |
| Fax |
|
| Email |
ayurvijay25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayesha Afnan |
| Designation |
MD Scholar (Manasaroga) |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research centre, Kuthpady |
| Address |
OPD3, Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady
Udupi
KARNATAKA
574118
India |
| Phone |
9591438360 |
| Fax |
|
| Email |
afnanaps007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Mnajunatheshwara Ayurveda Pharmacy, Laxminarayana 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 Ayesha Afnan |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady |
OPD3,Dept of Manasaroga,Shri Dharmasthala Manjunatheshwara College of Ayurveda,Hospital and Research Centre,Kuthpady
Udupi
KARNATAKA |
9591438360
afnanaps007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITEE-HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F432||Adjustment disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: TULSI, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: WARM WATER), Additional Information: - | | 2 | Comparator Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects who are professional students fulfilling diagnostic criteria of Adjustment Disorder as per DSM-5.
2) Subjects are selected of age group between 18-30years.
3) Subjects willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1) Subjects suffering from any systemic illness,
psychiatric illness or disorder interfering with the
treatment protocol.
2) Subjects suffering from substance abuse, cicardian rhythm disorder |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters will be scored by standard method and will be assessed before and after
treatment on 0th , 14th day.
1) Student adaptation to college Questionnaire by Baker & Siryk
2) Hamilton’s Anxiety rating scale
3) Manasika Bhava scale.
Statistical analysis:
All scored parameters will be analyzed statistically after the treatment on 14th day. 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. |
Parameters will be scored by standard method and will be assessed before and after
treatment on 0th , 14th 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 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Conceptual article accepted in UGC approved journal - Journal of ayurveda
Probable publication in June issue |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised open label parallel group study comparing the safety and efficacy of the trial drug Group A- Tulsi Capsule (500 mg) 2 BD, Before Food with warm water and Group B– Tulsi Capsule (500 mg) 2 BD, Before Food with warm water and Guided imagery meditation once daily for 10 mins for a period of 14 days. The study will be conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. The primary measures will be assessed through Student adaptation to college questionnaire by Baker and Siryk, Hamiltons anxiety rating scale, Manasika Bhava scale. Hence, the study is an effort to prove the efficacy and compare the effect of Tulsi capsules and Tulsi capsule along with Guided imagery meditation in professional students with Adjustment disorder. |