| 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
|
|
|
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
|
|
|
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. |