Female InfertilityPhase 3NCT02175498
Effectiveness of Homeopathic Treatment in Female Infertility
A Phase 3 study testing Homoeopathic medicines in people with Female Infertility, run by Fr Muller Homoeopathic Medical College at 1 site in India.
Trial summary
The purpose of this study is to assess the effectiveness of Homoeopathic treatment in female infertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility
- What is being tested?
- Homoeopathic medicines
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2014to Jun 2018
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only female causes
- Age group of 18-40 years
- Cases of PCOS, Endometriosis and Chronic PID
- Primary and secondary infertility
Who cannot join
- Age group below 18 years and beyond 40 years
- All other causes such as unknown infertility, congenital defects
- Women whose husband's semen analysis is abnormal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Assess the Effectiveness of Homeopathic Treatment in Female Infertility
The purpose of this study is to assess the effectiveness of Homoeopathic treatment in female infertility.
Read the detailed description
Objectives:
- To assess the rate of conception, in female infertility, after individualized homoeopathic treatment.
Need for the study:
- To confirm that homeopathy is best alternative for resource limited community to receive effective treatment with minimum possible expenditure.
- To bring out a repertoire of effective Homoeopathic medicines in the treatment of infertility.
- To establish a centre for focussed treatment of infertility at Father Muller Homeopathic Medical College and Hospital.
Many cases visiting Homoeopathic OPD have improved under the treatment. In general, there is a deficit of well-designed, randomized, controlled trials to evaluate the efficacy and safety of complementary and alternative medicine for these indications, which makes it difficult to provide evidence-based recommendations.
Globally there is a need for this study to avoid the side-effects of antibiotics and hormonal tablets thus improving the quality of life. In a third world country like India where infertile females cannot afford surgery; Homoeopathic medicines are simple, safe and cost effective. Homoeopathy can treat the underlying cause of female infertility in these cases and thereby prevent the hazards of surgery. In India the female race is always targeted and blamed for being infertile. This not only has an impact on the health of the woman but also affects her social status. The psychological and mental agony suffered by these infertile women and the fear that their husbands' may go in for a second marriage in turn causes great stress and anxiety. Hence the efficacy of Homoeopathic medicines on infertile females needs to be explored.
Methodology:
Approach: This is a prospective study with purposive sampling. Design: Total number of beneficiaries is 40, including 20 PCOS cases, 10 cases of Endometriosis, and 10 cases of Chronic Pelvic Inflammatory diseases. The numbers of these cases are based on the availability and frequency of their visits to our OPD.
Data collection instruments: case books of the OPD Setting: OPD of Homeopathic Medical College, Derlakatte, Kankanady and Thumbe Population: women visiting the OPD for infertility treatment Sample: women diagnosed for any of the three causes of infertility Sampling technique: purposive sampling Feasibility: the study is feasible in terms of availability of patients at our OPD settings Duration of study: total of 3 years. All 40 cases are expected to be registered in a span of 6 months to 1 year. Registration will be followed by treatment of 18 months, 6 months for analysis and reporting by the end of 3 years.
Statistical analysis: Data from the sample is collected and subjected to chi square test, and frequencies will be calculated.
Null Hypothesis: No significant difference in cases of female infertility before and after treatment.
Alternate Hypothesis: Significant difference in cases of female infertility before and after treatment.
Procedure:
Forty infertile women will undergo investigations like Ultrasonography of pelvis, diagnostic laparoscopy when needed and urine pregnancy test once in six months. The cases will be diagnosed by the principal investigators and co-investigators. Semen analysis in male partners will be done as a routine to rule out cases of male infertility. The infertile women will be administered appropriate Homoeopathic Simillimum by the principal investigator for 18 months. The follow-up visits of these patients will be once in two weeks. Effectiveness of Homoeopathic treatment and rate of conception in infertile females will be assessed after administering the Simillimum. The investigations will be repeated after treatment and cases will be reviewed and examined by the co-investigators.
The treatment given is individually chosen homoeopathic medicine based on the psychophysical symptom syndrome each experienced. The drugs are procured from Fr Muller HPD which complies with the standards of Homoeopathic Pharmacopoeia. The investigations will be repeated after treatment.
The Homoeopathic treatment includes a detailed interview in which the patient is queried about her unique symptoms. The well indicated constitutional remedy will be given on the basis of symptoms' similarity, that is, symptoms that were in emotional and mental realm and those that affected her entire body. The symptoms will be ordered by intensity and prominence. A single dose of Homoeopathic Similimum will be given to each of these patients and repeated as and when needed and whenever required the potency will be increased. If there is any miasmatic block, anti-miasmatic treatment will be given. Acute remedy will be given when needed. All cases of infertility are told to abstain from caffeine and Allopathic treatment. Hormonal treatment is to be withdrawn. The investigations will be repeated after treatment after six months, twelve months and eighteen months whenever required to assess the improvement of the patient.
- Conditions
- Female Infertility
- Being tested
- Homoeopathic medicines
- Keywords
- Homoeopathy Similimum female infertility
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homoeopathic medicinesDrug
Also called indicated Homoeopathic similimum
4 pills once a week of the indicated Similimum
| Study group | Role | What they receive |
|---|---|---|
| Homoeopathic medicines | Experimental | 4 pills once a week of the indicated similium for a period of one year Receives: Drug: Homoeopathic medicines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved fertility rate
Investigative parameters becoming normal
Measured: 3 years
Secondary outcomes (1)
Positive pregnancy test
Earlie Icon
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies 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
- 40 participants (actual)
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, Dr Anita Fernandes, Fr Muller Homoeopathic Medical College
- Investigators
- Dr Anita Fernandes, MD(HOM), Principal investigator, Fr Muller Homoeopathic Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175498
- Sponsor's protocol ID
- APB123
- Status last verified
- Jun 2018
- First submitted
- 25 Jun 2014
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Effectiveness of Homeopathic Treatment in Female Infertility
- ClinicalTrials.gov ID
- NCT02175498
- Acronym / sponsor ID
- APB123
- Conditions
- Female Infertility
- Keywords
- Homoeopathy Similimum female infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fr Muller Homoeopathic Medical CollegeUniversity, hospital or other
- Collaborators
- Father Muller Medical College
- Study start
- Jun 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 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.
The purpose of this study is to assess the effectiveness of Homoeopathic treatment in female infertility.
Detailed description
Objectives:
- To assess the rate of conception, in female infertility, after individualized homoeopathic treatment.
Need for the study:
- To confirm that homeopathy is best alternative for resource limited community to receive effective treatment with minimum possible expenditure.
- To bring out a repertoire of effective Homoeopathic medicines in the treatment of infertility.
- To establish a centre for focussed treatment of infertility at Father Muller Homeopathic Medical College and Hospital.
Many cases visiting Homoeopathic OPD have improved under the treatment. In general, there is a deficit of well-designed, randomized, controlled trials to evaluate the efficacy and safety of complementary and alternative medicine for these indications, which makes it difficult to provide evidence-based recommendations.
Globally there is a need for this study to avoid the side-effects of antibiotics and hormonal tablets thus improving the quality of life. In a third world country like India where infertile females cannot afford surgery; Homoeopathic medicines are simple, safe and cost effective. Homoeopathy can treat the underlying cause of female infertility in these cases and thereby prevent the hazards of surgery. In India the female race is always targeted and blamed for being infertile. This not only has an impact on the health of the woman but also affects her social status. The psychological and mental agony suffered by these infertile women and the fear that their husbands' may go in for a second marriage in turn causes great stress and anxiety. Hence the efficacy of Homoeopathic medicines on infertile females needs to be explored.
Methodology:
Approach: This is a prospective study with purposive sampling. Design: Total number of beneficiaries is 40, including 20 PCOS cases, 10 cases of Endometriosis, and 10 cases of Chronic Pelvic Inflammatory diseases. The numbers of these cases are based on the availability and frequency of their visits to our OPD.
Data collection instruments: case books of the OPD Setting: OPD of Homeopathic Medical College, Derlakatte, Kankanady and Thumbe Population: women visiting the OPD for infertility treatment Sample: women diagnosed for any of the three causes of infertility Sampling technique: purposive sampling Feasibility: the study is feasible in terms of availability of patients at our OPD settings Duration of study: total of 3 years. All 40 cases are expected to be registered in a span of 6 months to 1 year. Registration will be followed by treatment of 18 months, 6 months for analysis and reporting by the end of 3 years.
Statistical analysis: Data from the sample is collected and subjected to chi square test, and frequencies will be calculated.
Null Hypothesis: No significant difference in cases of female infertility before and after treatment.
Alternate Hypothesis: Significant difference in cases of female infertility before and after treatment.
Procedure:
Forty infertile women will undergo investigations like Ultrasonography of pelvis, diagnostic laparoscopy when needed and urine pregnancy test once in six months. The cases will be diagnosed by the principal investigators and co-investigators. Semen analysis in male partners will be done as a routine to rule out cases of male infertility. The infertile women will be administered appropriate Homoeopathic Simillimum by the principal investigator for 18 months. The follow-up visits of these patients will be once in two weeks. Effectiveness of Homoeopathic treatment and rate of conception in infertile females will be assessed after administering the Simillimum. The investigations will be repeated after treatment and cases will be reviewed and examined by the co-investigators.
The treatment given is individually chosen homoeopathic medicine based on the psychophysical symptom syndrome each experienced. The drugs are procured from Fr Muller HPD which complies with the standards of Homoeopathic Pharmacopoeia. The investigations will be repeated after treatment.
The Homoeopathic treatment includes a detailed interview in which the patient is queried about her unique symptoms. The well indicated constitutional remedy will be given on the basis of symptoms' similarity, that is, symptoms that were in emotional and mental realm and those that affected her entire body. The symptoms will be ordered by intensity and prominence. A single dose of Homoeopathic Similimum will be given to each of these patients and repeated as and when needed and whenever required the potency will be increased. If there is any miasmatic block, anti-miasmatic treatment will be given. Acute remedy will be given when needed. All cases of infertility are told to abstain from caffeine and Allopathic treatment. Hormonal treatment is to be withdrawn. The investigations will be repeated after treatment after six months, twelve months and eighteen months whenever required to assess the improvement of the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homoeopathic medicines | Experimental | Drug: Homoeopathic medicines4 pills once a week of the indicated similium for a period of one year |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
- Age group below 18 years and beyond 40 years
- All other causes such as unknown infertility, congenital defects
- Women whose husband's semen analysis is abnormal
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 medicinesAlso: indicated Homoeopathic similimum4 pills once a week of the indicated Similimum | Drug | Homoeopathic medicines |
Primary outcome
Improved fertility rate
Time frame: 3 years
Investigative parameters becoming normal
1 secondary outcome
Positive pregnancy test
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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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.
Dr Anita Fernandes, MD(HOM) principal investigator
Fr 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 medicines in people with Female Infertility, 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: finished, as of the sponsor's last update on 6 Jun 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved fertility rate (time frame: 3 years). 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 6 Jun 2018.