Clinical Trial Details
— Status: Unknown status
Administrative data
| NCT number |
NCT02154152 |
| Other study ID # |
enuresishmc |
| Secondary ID |
|
| Status |
Unknown status |
| Phase |
Phase 3
|
| First received |
May 30, 2014 |
| Last updated |
June 2, 2014 |
| Start date |
May 2014 |
| Est. completion date |
August 2015 |
Study information
| Verified date |
May 2014 |
| Source |
Fr Muller Homoeopathic Medical College |
| Contact |
Jyoshna Shivaprasad, MD (Hom) |
| Phone |
919342231894 |
| Email |
jyoshnashiv[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Homeopathic Medicine Causticum 200c will be prescribed in cases of Primary Enuresis on the
basis of available symptoms for a period of one year and the results will be evaluated at the
end of the given period and efficacy of the drug will be assessed.
Description:
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY
ENURESIS
AIMS & OBJECTIVES:
To assess and evaluate the efficacy of administering the Homoeopathic remedy Causticum 200
Centesimal potency based on Homoeopathic principles in management of Primary enuresis A total
number of 30 cases will be selected after screening 50 cases as per the inclusion criteria
from the Outpatient Department of Father Muller Homoeopathic Medical College for the study
and will be followed for a period of one year.
Inclusion criteria:
1. Age group between 5-15 yrs
2. Both sexes are included
3. Patients with Primary enuresis will be Included
4. Patients with Nocturnal or Diurnal enuresis will be included
Exclusion criteria:
1 Patients with metabolic illness like Diabetes Mellitus or Diabetes Insipidus will be
excluded 2. Congenital anomalies like horse shoe kidney, polycystic kidney will be excluded.
3. Presence of Malignancy, Mental Retardation and Cerebral palsy will be excluded.
The case shall be analyzed and prescribed the remedy Causticum in 200 Centesimal potency, 4
globules once a week for 3 months with placebo to follow for the next few months and general
management.
RESEARCH PLAN:
Purposive sampling will be followed in the study wherein patients who belong to the above
category of Inclusion criteria will be taken up and subjected to screening so as to confirm
the diagnosis of Enuresis.
Each patient will be treated for one year with Causticum 200C in the first 3 months along
with placebo to follow and attended to, once a week. At each follow-up they will be assessed
clinically for evaluating the improvement status.
The drug namely Causticum 200C potency will be ordered from Father Muller Homoeopathic
Pharmaceutical division, which complies with the standards of Homoeopathic Pharmacopeia of
India. The dosage shall be 4 globules prescribed once a week for 3 months with placebo to
follow for the remaining period. This medicine shall be advised half an hour before food.
RESEARCH METHODOLOGY AND STATISTICS:
Criteria for deciding the Efficacy of Homoeopathic medicine Causticum200C shall be based on
the following parameters:
1. Frequency of Enuresis
2. Odor of urine
3. Diurnal and Nocturnal urination
4. Modalities
PLAN FOR ANALYSIS: The collected data will be analyzed by paired 't' test to determine the
efficiency.
RESEARCH HYPOTHESIS: There is significant improvement among Primary Enuresis cases in
Paediatric age group after prescribing the Homoeopathic drug Causticum 200C.
NULL HYPOTHESIS: There is no significant improvement among Primary Enuresis cases in
Paediatric age group after prescribing the Homoeopathic drug Causticum 200C.
ALTERNATIVE HYPOTHESIS: Significant variation in the above parameters before and after
treatment.
