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CTRI Number  CTRI/2024/10/075935 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 19/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role Of Homoeopathy In Reducing DASS-21 Stress Score In Psychosomatic Disorders  
Scientific Title of Study   Evaluating Reduction Of DASS-21 Stress Score: 3rd Grade vs. 1st Grade Remedy using Mind-Ailments from as an Eliminative Rubric in Psychosomatic Disorders  
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 Tejaswinee Arun Mhaisale  
Designation  PG Scholar  
Affiliation  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital 
Address  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital, Dept. Of Repertory, Post Graduate And Research Centre, Floor No. 3, Pune-Bangalore Highway, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9657808809  
Fax    
Email  tejaswineemhaisale2018@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priya Rohit Sheth  
Designation  Assistant Professor  
Affiliation  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital 
Address  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital, Dept. Of Post Graduate And Research Centre, Pune-Bangalore Highway, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9403580523  
Fax    
Email  priya.sheth@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Tejaswinee Arun Mhaisale  
Designation  PG Scholar 
Affiliation  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital 
Address  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital, Dept. Of Post Graduate And Research Centre, Pune-Bangalore Highway, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9657808809  
Fax    
Email  tejaswineemhaisale2018@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College And Homoeopathic Hospital, Dept. Of Post Graduate And Research Centre, Pune-Bangalore Highway, Pune, Maharashtra, India - 411043  
 
Primary Sponsor  
Name  Dr Tejaswinee Arun Mhaisale  
Address  Bharati Vidyapeeth (Deemed To Be University), Homoeopathic Medical College And Homoeopathic Hospital, Dept. Of Post Graduate And Research Centre, Pune-Bangalore Highway, Pune, Maharashtra, India 411043 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejaswinee Arun Mhaisale  BVDU Homoeopathic Medical College And Hospital,Dept. Of Post Graduate And Research Centre  Repertory OPD, Department Of Repertory, Katraj, Dhankawadi, Pune 411043
Pune
MAHARASHTRA 		 9657808809

tejaswineemhaisale2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC Pune   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z733||Stress, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1st Grade Homoeopathic Remedy   1st Grade Homoeopathic medicine obtained after Repertorization of Synthesis Repertory using Mind-Ailments from as an Eliminative rubric in the form of Globules or Powder or Liquid. Route of administration: Oral route. Selection of potency: The drug will be administered in various potencies (30,200,1M) as per the requirement of the patient. Duration of Therapy: 3 months  
Intervention  3rd Grade Homoeopathic Remedy   3rd Grade Homoeopathic medicine obtained after Repertorization of Synthesis Repertory using Mind-Ailments from as an Eliminative rubric in the form of Globules or Powder or Liquid. Route of administration: Oral route. Selection of potency: The drug will be administered in various potencies (30,200,1M) as per the requirement of the patient. Duration of Therapy: 3 months  
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with complaints of psychosomatic disorders assessed by PSQ-39 scale will be included.
2. Age group varying from 18 to 60 years of both genders will be considered.
3. Patients having stress score more than 15 on DASS-21 scale will be included.
4. Patients willing to take part in the study.  
 
ExclusionCriteria 
Details  1. Patient with serious psychological, gross pathological disease will not be considered.
2. Patients which is on some psychotropic medications will not be considered.
3. Patients having stress score more than 33 on DASS-21 scale will be excluded.
4. Patient who may not be able to come for regular follow up will be excluded.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the difference in the stress score from DASS-21 scale between 3rd grade and 1st grade remedies using the rubric Mind-Ailments from in cases of psychosomatic disorders.  3 Months with follow-up in each 15 days. The outcome will be assessed by DASS-21 scale and PSQ-39 scale at baseline and after 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change in the score of PSQ-39 scale in cases of psychosomatic disorders.
 		 3 Months with follow-up in each 15 days.
The outcome will be assessed by PSQ-39 scale at baseline & after 3 months. 
To assess the effectiveness of intervention in patients having psychosomatic disorders.  The study duration will be 18 months. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   28/11/2024 
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 Yet Recruiting 
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 a Prospective, Single blind Randomized study. The primary objective of the study is to evaluate the difference in the stress score from DASS-21 scale between 3rd grade and 1st grade remedies using the rubric Mind-Ailments from as an eliminative rubric in cases of psychosomatic disorders. A survey off  patients coming in Bharati Vidyapeeth Medical Foundation Homoeopathic Hospital OPD, IPD, Peripheral OPD and various Rural and Urban camps conducted by Hospital will be done for screening them with psychosomatic disorders. Screening of patient will be done with PSQ-39 scale. Minimum 52 patients fulfilling the inclusion criteria will be enrolled in the study. The participants split into two equal groups: 26 patient receiving 3rd grade Remedy and 26 patient receiving 1st Grade Remedy. Follow up occurs every 15 days for 3 months. The final outcome will assessed by using the DASS-21 scale and PSQ-39 scale. 
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