| CTRI Number |
CTRI/2025/05/087398 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to evaluate the effect of Satvavajaya Chikitsa with Shankhapushpi capsule in Body Dysmorphic Disorder |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE ENHANCED EFFECT OF SATVAVAJAYA CHIKITSA WITH SHANKHAPUSHPI (CONVOLVULUS PLURICAULIS) CAPSULE IN BODY DYSMORPHIC DISORDER W.S.R TO CHINTA |
| Trial Acronym |
SC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyadarshini |
| Designation |
MD SCHOLAR ( MANASAROGA) |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady , Udupi |
| Address |
OPD3 ,Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady , Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7899216053 |
| Fax |
|
| Email |
priyapriyadarshini455@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayendra G Bhat |
| Designation |
HOD and Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady , Udupi |
| Address |
OPD3 ,Dept of Manasaroga , Shri Dharmasthala Manjunatheshwara 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 PRIYADARSHINI |
| Designation |
MD SCHOLAR (MANASAROGA) |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady , Udupi |
| Address |
OPD3 ,Dept of Manasaroga, Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady , Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448139919 |
| Fax |
|
| Email |
priyapriyadarshini455@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady , Udupi |
| Shri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research centre, Kuthpady , Udupi , Karnataka - 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRIYADARSHINI |
SDM COLLEGE OF AYURVEDA,HOPSITAL AND RESEARCH CENTRE |
KUTHPADY ,UDUPI
Udupi
KARNATAKA |
7899216053
priyapriyadarshini455@gmail.com |
| Dr Priyadarshini |
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 |
7899216053
priyapriyadarshini455@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , SDM College of Ayurveda, Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F458||Other somatoform 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: SHANKHAPUSHPI, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -WARM WATER), Additional Information: - | | 2 | Comparator Arm | Procedure | - | satvAvajaya-cikitsA, सत्वावजय-चिकित्सा | (Procedure Reference: CHARAKA SAMHITHA 9/79-85, Procedure details: Patient will be treated with supportive psychotherapy(Ashwasana and Santwana).Examin engages in fully emotional, encouraging and supportive equation with the patient as method of furthering healthy psychological defense mechanisms.
Along with this patient will be demonstrated to do dhyana and will be asked to follow sadvritta)
(1) Medicine Name: SHANKHAPUSHPI, Reference: API, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: tds, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters will be assessed on Day 0 and Day 14 using standard tools
1) Appearance Anxiety Inventory for BDD(Cambridge university)
2) Ham- A scale
3) WHO Quality of life scale
4) Manobhava scale
All the subjective
parameters and scales will be assessed statistically 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 and 14th day (at 2 weeks) |
|
|
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)
|
10/06/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Understanding of Body Dysmorphic Disorder - An Ayurvedic Conceptual Study- JAIMS JOURNAL |
|
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- 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. |