FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073994 [Registered on: 18/09/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy
Other (Specify) [ [Therapeutic effectiveness]]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A comparative study for comparing the efficacy of Argentum Nitricum vs homoeopathic individual medicine in the symptomatic management of irritable Bowels syndrome. 
Scientific Title of Study   Effect of Argentum Nitricum versus homoeopathic constitutional medicines in the symptomatic management of irritable bowel syndrome a prospective comparative study  
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 ARCHANA V KANOJIYA 
Designation  Post Graduate Scholar 
Affiliation  Government homoeopathic medical college kozhikode 
Address  Department of materia medica Government homoeopathic medical College kozhikode Kerala

Kozhikode
KERALA
673010
India 
Phone  8670202968  
Fax    
Email  archukanojiya09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr NIMI MOLE K L 
Designation  Professor and guide 
Affiliation  Kerela university of health science 
Address  Department of materia medica Government homoeopathic medical College kozhikode Kerala

Kozhikode
KERALA
673010
India 
Phone  8075888791  
Fax    
Email  nimimolekl@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr ARCHANA V KANOJIYA 
Designation  Pg scholar 
Affiliation  Government homoeopathic medical college kozhikode 
Address  Department of materia medica Government homoeopathic medical College kozhikode Kerala

Kozhikode
KERALA
673010
India 
Phone  8670202968  
Fax    
Email  archukanojiya09@gmail.com  
 
Source of Monetary or Material Support  
Government homoeopathic medical college karaparamba kozhikode Kerala 673010 India  
 
Primary Sponsor  
Name  Dr ARCHANA V KANOJIYA 
Address  postgraduate scholar Government homoeopathic medical college karaparamba kozhikode Kerala 673010 India 
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 ARCHANA V KANOJIYA  Government homoeopathic medical college karaparamba kozhikode Kerala 673010  Department of Materia medica room no 01 in general opd and room no 09 research opd in ground floor of Government Homoeopathic Medical College Karaparamba Kozhikode Kerala
Kozhikode
KERALA 		 8670202968

archukanojiya09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee government homoeopathic medical college kozhikode   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K588||Other irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Argentum Nitricum  Argentum Nitricum in various doses of 6C 30C and 200C, route of administration of medicine is orally and each case will be reviewed at a 2-3 weeks interval with follow-up for 3 month 
Comparator Agent  Homoeopathic constitutional medicine  Homoeopathic constitutional medicine in various doses of 30 and 200, route of administration of medicine is orally and each case will be reviewed at a 2-3 weeks interval with follow-up for 3 month 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and female patients between the age group 18 to 60 years.
2. Patients who are willing to give written consent to participate in the study.
3. Those who satisfy case definition - ROME IV diagnostic criteria for Irritable bowel syndrome.
CASE DEFINITION
Patients satisfying ROME IV diagnostic criteria for irritable bowel syndrome.
Recurrent abdominal pain on average 1 day per week in the last 3 months associated with
two or more of the following
1. Related to defecation
2. Associated with a change in frequency of stool
3. Associated with change in the form (appearance) of the stool. 
 
ExclusionCriteria 
Details  1. cases with other serious illnesses such as malignancy condition and any history of previous gastrointestinal surgery or gastrointestinal bleeding.
2.Patients taking drugs such as anticholinergic, antidepression and anti- inflammatory or other toxic agents.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the interventional effects of argentum nitricum and homoeopathic constitutional medicine in the symptomatic improvement of patients with irritable bowel syndrome by assessing the irritable bowel syndrome Severity scoring system   Each case will be reviewed at baseline 2week , 3 weeks and after 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the relative effects of various potencies (6C 30C and 200C) of Argentum
nitricum in the symptomatic improvement of patients with irritable bowel syndrome. 		 Each case will be reviewed at a 2- 3 weeks interval with follow-up for a period of 3
month. 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   22/09/2024 
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="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  
Irritable bowel syndrome is defined as a chronic functional bowel disorder of the gastrointestinal tract characterised by recurrent abdominal pain in association with abnormal defecation in the absence of detectable structural abnormalities of the gut. The most typical signs and symptoms include the onset of pain during emotional upset, abdominal pain in the epigastric region, abdominal bloating, alternating diarrhoea and constipating spells, and often mucus in the stools. IBS (Irritable bowel syndrome) is only at the functional level and no structural pathological changes exist.
Homoeopathy’s holistic approach lacks side effects and cost-effectiveness, providing it with a wide range of therapeutic applications. It is highly effective in functional psychosomatic illnesses like IBS. In Homoeopathy, Importance is given to psyche symptoms and bowel symptoms in the treatment plan. 
Argentum nitricum has marked action on the gastroenteritic system. In A Dictionary of Clarke Materia medica by J.H Clarke Argentum nitricum has digestive upsets accompanied by nervousness and 
anxiety suggesting the use of this remedy. The constitutional and miasmatic approach also plays an important role in the cure of IBS.
However, there are few trials on homoeopathy for the treatment of IBS. No comparative studies were conducted on the relative effect of Argentum nitricum versus homoeopathic constitutional medicine. 
Therefore, the purpose of this study is to compare the effects of Argentum nitricum and homoeopathic constitutional medicine in patients with irritable bowel syndrome.
 
Close