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

NCT03579303 | Unknown DMC

• 1 other identifier: AJP123
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Disorders; Polycystic Ovary Syndrome

Keywords

Homoeopathy; Yoga

Outcome Measures

Primary Outcomes (1)

• To assess if the interventions can facilitate regular menstrual cycle.

  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

  3yrs

Secondary Outcomes (1)

• To assess reduction in hyperandrogenism

  3yrs

Study Arms (2)

Homoeopathic remedies in PCOS

ACTIVE COMPARATOR

Homoeopathic treatment for menstrual disorders in females with PCOS

Other: Homoeopathic Remedies

Homoeopathic remedies and yoga in PCOS

ACTIVE COMPARATOR

Homoeopathic treatment integrated with yoga therapy for menstrual disorders in females with PCOS

Other: Homoeopathic Remedies

Interventions

Homoeopathic Remedies OTHER

comparison between homoeopathic treatment and integrated approach of homoeopathy and yoga in menstrual disorders of females with PCOS

Also known as: Homoeopathic remedies and yoga therapy

Homoeopathic remedies and yoga in PCOS; Homoeopathic remedies in PCOS

Eligibility Criteria

• Age: 18 Years - 36 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fr Muller Homoeopathic Medical College: lead

Study Sites (1)

Fr Muller Homoeopathic Medical College

Mangalore, Karnataka, 575018, India

RECRUITING

Related Publications (4)

• Prapas N, Karkanaki A, Prapas I, Kalogiannidis I, Katsikis I, Panidis D. Genetics of polycystic ovary syndrome. Hippokratia. 2009 Oct;13(4):216-23.

  PMID: 20011085 RESULT

• Badawy A, Elnashar A. Treatment options for polycystic ovary syndrome. Int J Womens Health. 2011 Feb 8;3:25-35. doi: 10.2147/IJWH.S11304.

  PMID: 21339935 RESULT

• Bern MJ, Sturbaum CW, Karayalcin SS, Berschneider HM, Wachsman JT, Powell DW. Immune system control of rat and rabbit colonic electrolyte transport. Role of prostaglandins and enteric nervous system. J Clin Invest. 1989 Jun;83(6):1810-20. doi: 10.1172/JCI114086.

  PMID: 2723060 RESULT

• Nidhi R, Padmalatha V, Nagarathna R, Amritanshu R. Effects of a holistic yoga program on endocrine parameters in adolescents with polycystic ovarian syndrome: a randomized controlled trial. J Altern Complement Med. 2013 Feb;19(2):153-60. doi: 10.1089/acm.2011.0868. Epub 2012 Jul 18.

  PMID: 22808940 RESULT

Related Links

• Yoga Exercises for PCOS \| PCOS Treatment
• Boyle J, Teede H J,Polycystic ovary syndrome An update :Volume 41, No.10, October 2012 Pages 752-756.

MeSH Terms

Conditions

Menstruation Disturbances; Polycystic Ovary Syndrome

Interventions

Yoga

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• 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 CHAIR

Central Study Contacts

Dr Anita Lobo, MD HOM

CONTACT

9342436337; dr_anitablany@rediffmail.com

Dr Jolly D'Mello, MD HOM

CONTACT

9845250425; jollydmello@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 6, 2018
• Study Start: October 1, 2018
• Primary Completion: April 15, 2021
• Study Completion: October 15, 2021
• Last Updated: July 9, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

IN (1)