| CTRI Number |
CTRI/2024/03/063707 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Role of Homoeopathic medicines in treatment of children with worms. |
|
Scientific Title of Study
|
A clinical study to access the effectiveness of Calcarea carb., Cina & Sulphur in children with
Ascariasis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raxitkumar Ramavat |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Rajkot Homoeopathic Medical College.
Department of Homoeopathic materia medica.
Rajkot
GUJARAT
360002
India |
| Phone |
8460077001 |
| Fax |
|
| Email |
raxitramavat.rr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankit Dubey |
| Designation |
Professor, HOD, Principal. |
| Affiliation |
Homoeopathic medical college & hospital, Chandigrah. |
| Address |
Homoeopathic medical college & hospital, Chandigrah.
Department of
Homoeopathic materia medica.
Chandigarh
CHANDIGARH
160019
India |
| Phone |
9882244568 |
| Fax |
|
| Email |
doctorankit79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raxitkumar Ramavat |
| Designation |
Assistant Professor |
| Affiliation |
Rajkot Homoeopathic medical college. |
| Address |
Rajkot Homoeopathic medical college.
Department of
Homoeopathic materia medica.
Rajkot
GUJARAT
360002
India |
| Phone |
8460077001 |
| Fax |
|
| Email |
raxitramavat.rr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College, Makkam chowk, Rajkot. |
|
|
Primary Sponsor
|
| Name |
Raxitkumar Ramavat |
| Address |
Rajkot |
| 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 |
| Raxitkumar Ramavat |
Sainath Homoeopathic hospital, Rajkot. |
Paediatric department.
Room : 104.
Rajkot
GUJARAT |
846007001
raxitramavat.rr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research Rajkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B770||Ascariasis with intestinal complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcarea carbonica, Cina,
Sulphur. |
Calcarea carbonica, Cina,
Sulphur.
Potency : 30,200,1M,10M, etc. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children of both sexes & all age groups from 1 to 14 years will be consider.
All socio economic class will be consider. |
|
| ExclusionCriteria |
| Details |
Complicated cases with advanced & irreversible pathological
conditions.
Cases with irregular follow ups. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
I will study the effectiveness of Calcarea carbonica, Cina & Sulphur, after prescription changes will be observe.
Changes in Stool investigation report will be observe. |
As per case requirements : 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prepare a kit of Homoeopathic medicine for treatment of worms. |
Results seen in 18 months of study. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/03/2024 |
| 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
|
Ascaris is a nematode genus of parasitic worms known as the "Small intestinal roundworms", which is a type of parasitic worm is known as Ascaris lumbricoides.Round worm infestation: is very common disorder among children, it is ranging from 0.6 to 96%. Common Age groups: Children between 1 to 14 years of age. Mode of infection: Faeco oral & Cutaneous. -SIGN & SYMPTOMS:->Due to the migrating larvae:Larvae in the lungs: Ascaris pneumonia (Loeffler’s Syndrome), In heavy infection typical symptoms of pneumonia such as fever, cough, dyspnoea may appear, Sputum is often blood tinged may contain ascaris larvae, Urticarial rash & Eosinophilia(20%). ->Due to the Adult worms: -History of passing roundworms. -Chronic indigestion. -Malnutrition & Stunted physical growth. -GIT: Abdominal pain, Nausea, Vomiting, Loss of Appetite, Peri anal itch. -Grinding of Teeth, increase in Salivation. -Respiratory system: Wheezing, Cough, dyspnea, mild Haemoptysis. -Fever & sometimes seizures may present. -Anemia. Samuel Hahnemann writes in Organon Of Medicine, There is a semblance of necessity in the expulsion by purgatives of worms, In so called vermicular diseases. But even this semblance is false. A few lumbric; may found in some children; in many there exist ascarides. But the presence of there is always dependent on a General taint of the constitution (the psoric), joined to an unhealthy mode of living. “Let the latter be improved, and the former cured homoeopathically, which is most easily affected at this age, and none of the worms remain, and children cured in this manner are never troubled with more; whereas after mere purgatives, even when combined with cina seeds, they soon reappear in quantities.†Our Homoeopathic medicines will not only eradicate worm but also helps to improve overall Health condition of the individual. With correct constitutional Homoeopathic treatment there is very less chance of Re-occurance of worms. So, With appropriate Homoeopathic medicines, we are improving the overall health, so ultimately “OUR HEALTHY BABY.â€
Material & methodology : Site : Sainath Homoeopathic hospital. Study type : Clinical study. Size : 100 cases. Inclusion criteria : Children of both sexes & all age groups from 1 to 14 years will be consider. All socio economic class will be consider.
Exclusion criteria : Complicated cases with advanced & irreversible pathological conditions.
Cases with irregular follow ups.
Purpose : Homoeopathic medicines are very much effective in treatment of worms & with Homoeooathic remedy chances of recurrence is rare, so i want to contribute in Deworming campaign. |