A clinical trail to evaluate the effect of Satvavajaya Chikitsa with Shankhapushpi capsule in Body Dysmorphic Disorder

Phase 2

Not yet recruiting

• Conditions: Other somatoform disorders. Ayurveda Condition: MANOVAHASROTOVIKARAH,

• Registration Number: CTRI/2025/05/087398

Brief Summary

This is a randomised open label parallel group study comparing the safety and efficacy of the trial drug Group A- Shankhapushpi Capsule (500 mg) 2 TID, Before Food with warm water and Group B– Shannkhapushpi Capsule (500 mg) 2 tid, Before Food with warm water and Satvavajaya Chikitsa once daily  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 throughAppearance anxiety Inventory for body dysmorphic disorder by Cambridge University of press and assessment , Manasika Bhava scale. Hence, the study is an effort to prove the efficacy and compare the effect of Shankhapushpi capsules and Shankhapushpi capsule along with Satvavajaya Chikitsa in Body Dysmorphic Disorder.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-05-19
• Study Start: 2025-10-06

Recruitment & Eligibility

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

Inclusion Criteria

1)Individuals fulfilling diagnostic criteria of Body Dysmorphic Disorder as per DSM-5 2)Achintana, Atichintana 3)Patients are selected of age group between 18-40 years 4)Patients willing to sign informed consent.

Exclusion Criteria

1)Patients suffering from any systemic illness, psychiatric illness or any other metabolic disorders interfering with the treatment protocol 2)Pregnant and lactating women 3)Patient suffering from substance abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2) Ham- A scale	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
3) WHO Quality of life scale	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
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 and 14th day (at 2 weeks)
4) Manobhava scale	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
All the subjective	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
parameters and scales will be assessed statistically using Wilcoxon signed rank test within the groups and	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
Parameters will be assessed on Day 0 and Day 14 using standard tools	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)
1) Appearance Anxiety Inventory for BDD(Cambridge university)	Parameters will be scored by standard method and will be assessed before and after treatment on 0th and 14th day (at 2 weeks)

Trial Locations

Locations (2)

SDM COLLEGE OF AYURVEDA,HOPSITAL AND RESEARCH CENTRE; 🇮🇳 Udupi, KARNATAKA, India

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

SDM COLLEGE OF AYURVEDA,HOPSITAL AND RESEARCH CENTRE

🇮🇳Udupi, KARNATAKA, India

DR PRIYADARSHINI

Principal investigator

7899216053

priyapriyadarshini455@gmail.com