Bed WettingPhase 3PENCT02154152
A Clinical Study on Causticum 200 Centesimal Potency in Primary Enuresis
A Phase 3 study testing Homoeopathic Medicine causticum 200c in people with Bed Wetting and Primary Enuresis, run by Fr Muller Homoeopathic Medical College at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Bed Wetting, Primary Enuresis
- What is being tested?
- Homoeopathic Medicine causticum 200c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- May 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Age group between 5-15 yrs
- Both sexes are included
- Patients with Primary enuresis will be Included
- Patients with Nocturnal or Diurnal enuresis will be included
Who cannot join
- •Patients with metabolic illness like Diabetes Mellitus or Diabetes Insipidus will be excluded
- Congenital anomalies like horse shoe kidney, polycystic kidney will be excluded.
- Presence of Malignancy, Mental Retardation and Cerebral palsy will be excluded.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Father Muller Homoeopathic Medical College
Mangalore, Karnataka, 575018
Jyoshna Shivaprasad, BHMS, MD (Hom)
About this study
Official title: A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS
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.
Read the detailed 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:
- Age group between 5-15 yrs
- Both sexes are included
- Patients with Primary enuresis will be Included
- 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.
- 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:
- Frequency of Enuresis
- Odor of urine
- Diurnal and Nocturnal urination
- 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.
- Conditions
- Bed Wetting, Primary Enuresis
- Being tested
- Homoeopathic Medicine causticum 200c
- Keywords
- Bed wetting, Primary Enuresis, Frequency, Efficacy, Homoeopathic Medicine, Causticum 200c
- Medical subject headings
- Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homoeopathic Medicine causticum 200cDrug
Also called Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali
| Study group | Role | What they receive |
|---|---|---|
| Homoeopathic Medicine Causticum | Experimental | The drug namely Causticum 200C potency shall be administered as 4 globules, prescribed once a week for 3 months with placebo to follow for the remaining period. Receives: Drug: Homoeopathic Medicine causticum 200c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bring down frequency of bed wetting
The patients with nocturnal enuresis will receive causticum 200c on weekly basis and results expected by one month.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bed WettingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fr Muller Homoeopathic Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Father Muller Medical College
- Responsible party
- Principal investigator, Jyoshna Shivaprasad, Fr Muller Homoeopathic Medical College
- Investigators
- Jyoshna Shivaprasad, MD (Hom), Principal investigator, Father Muller Homoeopathic Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154152
- Sponsor's protocol ID
- enuresishmc
- Acronym
- PE
- Status last verified
- May 2014
- First submitted
- 30 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A CLINICAL STUDY TO EVALUATE THE EFFICACY OF CAUSTICUM 200C IN THE TREATMENT OF PRIMARY ENURESIS
- ClinicalTrials.gov ID
- NCT02154152
- Acronym / sponsor ID
- PE / enuresishmc
- Conditions
- Bed Wetting, Primary Enuresis
- Keywords
- Bed wetting, Primary Enuresis, Frequency, Efficacy, Homoeopathic Medicine, Causticum 200c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fr Muller Homoeopathic Medical CollegeUniversity, hospital or other
- Collaborators
- Father Muller Medical College
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Age group between 5-15 yrs
- Both sexes are included
- Patients with Primary enuresis will be Included
- 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.
- 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:
- Frequency of Enuresis
- Odor of urine
- Diurnal and Nocturnal urination
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homoeopathic Medicine Causticum | Experimental | Drug: Homoeopathic Medicine causticum 200cThe drug namely Causticum 200C potency shall be administered as 4 globules, prescribed once a week for 3 months with placebo to follow for the remaining period. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Age group between 5-15 yrs
Key exclusion criteria (3 listed)
- •Patients with metabolic illness like Diabetes Mellitus or Diabetes Insipidus will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homoeopathic Medicine causticum 200cAlso: Potassium Hydrate, Hahnemann's Tinctura Acris Sine Kali | Drug | Homoeopathic Medicine Causticum |
Primary outcome
Bring down frequency of bed wetting
Time frame: 1month
The patients with nocturnal enuresis will receive causticum 200c on weekly basis and results expected by one month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jyoshna Shivaprasad, MD (Hom) principal investigator
Father Muller Homoeopathic Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Homoeopathic Medicine causticum 200c in people with Bed Wetting and Primary Enuresis, run by Fr Muller Homoeopathic Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyoshna Shivaprasad, MD (Hom) (919342231894, jyoshnashiv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bring down frequency of bed wetting (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.