Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579303
Recruitment Status : Unknown
Verified July 2018 by Dr Anita Fernandes, Fr Muller Homoeopathic Medical College.
Recruitment status was:  Recruiting
First Posted : July 6, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Anita Fernandes, Fr Muller Homoeopathic Medical College

Brief Summary:
This study is undertaken to compare effectiveness of homoeopathic treatment versus integrated approach of homoeopathy and yoga in the treatment of menstrual disorders in females with Polycystic ovarian syndrome.

Condition or disease Intervention/treatment Phase
Menstrual Disorders Polycystic Ovary Syndrome Other: Homoeopathic Remedies Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of Homoeopathic Treatment Versus Integrated Approach of Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Homoeopathic remedies in PCOS
Homoeopathic treatment for menstrual disorders in females with PCOS
Other: Homoeopathic Remedies
comparison between homoeopathic treatment and integrated approach of homoeopathy and yoga in menstrual disorders of females with PCOS
Other Name: Homoeopathic remedies and yoga therapy

Active Comparator: Homoeopathic remedies and yoga in PCOS
Homoeopathic treatment integrated with yoga therapy for menstrual disorders in females with PCOS
Other: Homoeopathic Remedies
comparison between homoeopathic treatment and integrated approach of homoeopathy and yoga in menstrual disorders of females with PCOS
Other Name: Homoeopathic remedies and yoga therapy




Primary Outcome Measures :
  1. To assess if the interventions can facilitate regular menstrual cycle. [ Time Frame: 3yrs ]
    Assessment of regularity in menstrual cycles will be done during the patients monthly visits to the out patient department ,recording the last menstrual period and duration of menses through a questionnaire


Secondary Outcome Measures :
  1. To assess reduction in hyperandrogenism [ Time Frame: 3yrs ]

    Assessment of reduction in hyperandrogenism will be done by Ferriman-Gallwey scale for hirsutism (Ref-Ferriman DM, Gallwey JD. Clinical assessment of body hair growth in women. J ClinEndocrinol 1961:21:1440-1447).

    Assessment of serum testosterone levels before and after treatment




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female aged 18-36years
  • Females diagnosed with Polycystic ovarian syndrome according to Rotterdam criteria.
  • Participants willing to adopt a healthy life style and regularly practice yoga (at least 30 minutes for 5 days a week).

Exclusion Criteria:

  • Diabetes mellitus, Cushing's disease, hyper-prolactinemia
  • Untreated hypo or hyperthyroidism
  • Adrenal hyperplasia and adrenal tumour
  • Ovarian tumour hyperthecosis
  • History of intake of drugs aldactone/metformin or history of oral contraceptive pills (OCP) use or intake of drugs known to interfere with carbohydrate metabolism 4 weeks prior to enrolment pregnancy, breast feeding cases with any systemic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579303


Contacts
Layout table for location contacts
Contact: Dr Anita Lobo, MD HOM 9342436337 ext 0824-2203902 dr_anitablany@rediffmail.com
Contact: Dr Jolly D'Mello, MD HOM 9845250425 ext 0824-2203902 jollydmello@gmail.com

Locations
Layout table for location information
India
Fr Muller Homoeopathic Medical College Recruiting
Mangalore, Karnataka, India, 575018
Contact: Dr Anita Lobo, MD HOM    9342436337 ext 0824-2203902    dr_anitablany@rediffmail.com   
Contact: Dr Jolly D'Mello, MD HOM    9845250425 ext 0824-2203902    jollydmello@gmail.com   
Sub-Investigator: Dr Subramanya Pailoor, Ph.D         
Sub-Investigator: Dr Prema D'Cunha, MD DNB         
Sponsors and Collaborators
Fr Muller Homoeopathic Medical College
Investigators
Layout table for investigator information
Study Chair: Dr. Subramanya Pailoor, Ph.D. Central University of Kerala, Kasaragod,
Study Chair: Dr Prema D'Cunha, MD,DNB Father Muller Medical college,Kankanady,Mangalore
  Study Documents (Full-Text)

Documents provided by Dr Anita Fernandes, Fr Muller Homoeopathic Medical College:
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 123
De-identified data for primary and secondary outcome measures

Publications of Results:
Layout table for additonal information
Responsible Party: Dr Anita Fernandes, Professor, Fr Muller Homoeopathic Medical College
ClinicalTrials.gov Identifier: NCT03579303    
Other Study ID Numbers: AJP123
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available .
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be made available within 6 months of study completion.
Access Criteria: Data access request will be reviewed by a external independent review panel. Requester's will be required to sign a data assess agreement.
URL: http://bethesda.org

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Anita Fernandes, Fr Muller Homoeopathic Medical College:
Homoeopathy
Yoga
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Syndrome
Menstruation Disturbances
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases