MenorrhagiaNCT01460043
Trial of Homeopathy on Management of Menorrhagia
A study testing Homeopathy in people with Menorrhagia, run by NMP Medical Research Institute.
Trial summary
The purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Read more about this study
- Who is it for?
- Ages 35 to 49 years, women only
- Conditions the study is for
- Menorrhagia
- What is being tested?
- Homeopathy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jun 2009
- Phase
- Interventional
- 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 35 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 35-49 years with regular heavy menstrual bleeding
- menstrual loss requiring more than 5 Pads/tampons per day
- menstrual cycle longer than 6 days
Who cannot join
- Organic causes of menorrhagia
- History of renal or hepatic impairment,
- Endocrine disorder including diabetes, thyroidism
- Thromboembolic disease,
- Inflammatory bowel disease,
- Peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and --Malignancy.
About this study
Official title: Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
The purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal \& back pain, General health and overall satisfaction.
- Conditions
- Menorrhagia
- Being tested
- Homeopathy, placebo
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeopathyDrug
Each homeopathic medication was given as 1 g dose of homeopathic preparation in 30c potency. The dose is prepared as lactose globules on which the homeopathic preparation.
placeboDrug
corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Homeopathy | Experimental | Individualized symptom based therapy Receives: Drug: Homeopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily assessment of bleeding
bleeding days, intensity of bleeding, average pads used, back and abdominal pain associated.daily assessment during menses were completed by participants at baseline before randomization and at each menses for 3 month of intervention period.
Measured: change from baseline over 3 months
Secondary outcomes (1)
Health related quality of life
Measured: change from baseline over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Principal investigator, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460043
- Sponsor's protocol ID
- NMP-0032-HR
- Status last verified
- Oct 2011
- First submitted
- 18 Oct 2011
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Homeopathy in Dysfunctional Uterine Bleeding Presenting as Menorrhagia
- ClinicalTrials.gov ID
- NCT01460043
- Acronym / sponsor ID
- NMP-0032-HR
- Conditions
- Menorrhagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Oct 2011 (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 compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal \& back pain, General health and overall satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| Homeopathy | Experimental | Drug: HomeopathyIndividualized symptom based therapy |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 35-49 years with regular heavy menstrual bleeding
- menstrual loss requiring more than 5 Pads/tampons per day
- menstrual cycle longer than 6 days
Key exclusion criteria (6 listed)
- Organic causes of menorrhagia
- History of renal or hepatic impairment,
- Endocrine disorder including diabetes, thyroidism
- Thromboembolic disease,
- Inflammatory bowel disease,
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 |
|---|---|---|
| HomeopathyEach homeopathic medication was given as 1 g dose of homeopathic preparation in 30c potency. The dose is prepared as lactose globules on which the homeopathic preparation. | Drug | Homeopathy |
| placebocorresponding placebo was identical in appearance of homeopathic globule prepared in alcohol. | Drug | placebo |
Primary outcome
daily assessment of bleeding
Time frame: change from baseline over 3 months
bleeding days, intensity of bleeding, average pads used, back and abdominal pain associated.daily assessment during menses were completed by participants at baseline before randomization and at each menses for 3 month of intervention period.
1 secondary outcome
Health related quality of life
Time frame: change from baseline over 3 months
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 10 Nov 2011.
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Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
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HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
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Delivering tAN to Reduce HMB: The LUNA Study
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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.
Neha Sharma principal investigator
NMP Medical Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Homeopathy in people with Menorrhagia, run by NMP Medical Research Institute.
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 3 inclusion and 6 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 10 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
daily assessment of bleeding (time frame: change from baseline over 3 months). 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 10 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.