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CTRI Number  CTRI/2023/09/057286 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 05/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Argentum Nitricum in cases of irritate bowel syndrome 
Scientific Title of Study   Prospective interventional study to assess effectiveness of Argentum Nitricum in cases of Irritate Bowel Syndrome 
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 Mahima Pandya 
Designation  MD Homoeopathy Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University 
Address  Post Graduation Department of Homoeopathic Materia Medica,Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University, At Post Limda Ta: Waghodia Dist: Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9327422471  
Fax    
Email  mahipandya08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Munjal Thakar 
Designation  Professor 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University 
Address  Post Graduation Department of Homoeopathic Materia Medica,Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University, At Post Limda Ta: Waghodia Dist: Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9227926514  
Fax    
Email  munjal.thakarahmc@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Mahima Pandya 
Designation  MD Homoeopathy Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University 
Address  Post Graduation Department of Homoeopathic Materia Medica,Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University, At Post Limda Ta: Waghodia Dist: Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9327422471  
Fax    
Email  mahipandya08@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University 
 
Primary Sponsor  
Name  NIL 
Address  NA 
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 Mahima Pandya  Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University  Post Graduation Department of Homoeopathic Materia Medica,Jawaharlal Nehru Homoeopathic Medical College and Hospital,Parul University, At Post Limda Ta: Waghodia Dist: Vadodara
Vadodara
GUJARAT 
9327422471

mahipandya08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K58||Irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ARGENTUM NITRICUM  Intervention is planned as administering Argentum Nitricum as decided to case or condition. each dose shall consist of 4-5 globules (no.30)of cane sugar, medicated with a single drop of argentum Nitricum (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach, dosage and repetition depending upon the individual requirement of the cases. Intervention of medicine will be for 6 months for each patient. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Pre diagnosed or with clinical presentation of IBS
will be randomly selected confirmed with Rome
criteria
-All socio economic status
 
 
ExclusionCriteria 
Details  -Having gross pathological changes
-Suffering from other diseases along with ibs
-Cases with irregular follow ups
-Pregnant and lactating woman
-Severely ill patients who requires immidiate
hospitalization
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of Argentum Nitricum in cases of IBS  3 months,6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of Irritable Bowel Syndrome on individuals using IBS severity scoring system  3 months,6 Months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/09/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The word ‘psychosomatic’ means mind or ‘psyche’ and body or ‘soma’. A Psychosomatic Disorders is a disease involving both mind and body, in other words. some physical diseases are prone to worsen by anxiety and stress. it is a condition of dysfunction or structural damage in bodily organs through inappropriate activation of the involuntary nervous system and the glands of internal secretion. There are many psychosomatic disorders like peptic ulcer, rheumatoid arthritis, cardiovascular diseases, diabetes mellitus, thyrotoxicosis, ulcerative colitis etc. IBS is one of the psychosomatic disorders. IBS is a functional bowel disease in which abdominal pain is associated with defecation or a change in bowel habit. It is a disorder of the young people with most new cases presenting before 45 years. Reports suggests that the elderly are troubled by IBS symptoms up to 92% as often as middle-aged persons. women are diagnosed with IBS 2-3 times more often as men and make up 80% of the population with severe IBS. Global prevalence of IBS is 11.2% and reported 4.2-7.5% prevalence in the Indian population. In conventional method the treatment is symptomatic such as anti-depressants, anti-diarrheal drugs, various laxatives which possess dozens of adverse effects such as nausea, headache, loss of appetite, dizziness etc. and dependency, withdrawal symptoms. All these ailments are treated well with homoeopathic medicines. Among them argentum nitricum is frequently uses for the treatment of IBS. It has neurotic effects, watery, noisy, flatulent, chopped spinach like green stool with shreddy mucus, diarrhea after eating, after  emotion with flatulence. This medicine is successfully used in complaints of IBS on basis of symptom similarity without producing any further adverse effects. So, the initiative has been taken to show the efficacy of homoeopathic medicine argentum nitricum in treatment of IBS.

 
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