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

Phase 2

Not yet recruiting

• Conditions: Adjustment disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH,

• Registration Number: CTRI/2025/04/084876

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-15
• Study Start: 2025-05-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Statistical analysis:	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
the subjective parameters and scales will be assessed using Wilcoxon signed rank test	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
3) Manasika Bhava scale.	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
All scored parameters will be analyzed statistically after the treatment on 14th day. All	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
treatment on 0th , 14th day.	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	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
2) Hamilton’s Anxiety rating scale	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
Parameters will be scored by standard method and will be assessed before and after	Parameters will be scored by standard method and will be assessed before and after | treatment on 0th , 14th day.
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.

Trial Locations

Locations (1)

Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady; 🇮🇳 Udupi, KARNATAKA, India

Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady

🇮🇳Udupi, KARNATAKA, India

Dr Ayesha Afnan

Principal investigator

9591438360

afnanaps007@gmail.com