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Menstrual DisordersNCT03579303

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

A study testing Homoeopathic Remedies in people with Menstrual Disorders and Polycystic Ovary Syndrome, run by Fr Muller Homoeopathic Medical College at 1 site in India.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 36 years, women only
What is being tested?
Homoeopathic Remedies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteIndia
Study dates
Oct 2018to 15 Oct 2021
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 18 to 36 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site, 1 recruiting
  • Fr Muller Homoeopathic Medical College

    Mangalore, Karnataka, 575018

    Dr Anita Lobo, MD HOM, 9342436337 ext. 0824-2203902, dr_anitablany@rediffmail.com

    Dr Jolly D'Mello, MD HOM, 9845250425 ext. 0824-2203902, jollydmello@gmail.com

    Recruiting

Other trials in India

About this study

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.

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.

Read the detailed description

Polycystic ovarian syndrome (PCOS) is a complex metabolic, endocrine and reproductive disorder affecting approximately 5-10% of the female population in developed countries. The developing countries like China and India, undergoing rapid nutritional transitions due to westernised diets and lifestyle also indicate similar prevalence (9.13%). Its prevalence among infertile women is 15%-20%. The aetiology of Polycystic ovarian syndrome remains unclear; however, several studies have suggested that Polycystic ovarian syndrome is X-linked dominant condition.Women with Polycystic ovarian syndrome have abnormalities in the metabolism of androgens and oestrogen and in the control of androgen production. High serum concentrations of androgenic hormones, such as testosterone, androstenedione, and dehydroepiandrosterone sulfate (DHEAS), may be encountered in these patients. However, individual variation is considerable, and a particular patient might have normal androgen levels.

Polycystic ovarian syndrome is also associated with peripheral insulin resistance and hyperinsulinemia, and obesity amplifies the degree of both abnormalities. Insulin resistance in Polycystic ovarian syndrome can be secondary to a post binding defect in insulin receptor signalling pathways, and elevated insulin levels may have gonadotropin-augmenting effects on ovarian function. In addition, insulin resistance in Polycystic ovarian syndrome has been associated with adiponectin, a hormone secreted by adipocytes that regulates lipid metabolism and glucose levels. Both lean and obese women with Polycystic ovarian syndrome have lower adiponectin levels than women without Polycystic ovarian syndrome .

An anovulation and elevated androgen level suggests that under the increased stimulatory effect of luteinizing hormone (LH) secreted by the anterior pituitary, stimulation of the ovarian theca cells is increased. In turn, these cells increase the production of androgens (eg, testosterone, androstenedione). Because of a decreased level of follicle-stimulating hormone (FSH) relative to LH, the ovarian granulosa cells cannot aromatize the androgens to estrogens, which lead to decreased estrogen levels and consequent anovulation. Growth hormone and insulin-like growth factor 1 may also augment the effect on ovarian functioning.

The clinical manifestation of Polycystic ovarian syndrome varies from a mild menstrual disorder to severe disturbance of reproductive and metabolic functions. Women with Polycystic ovarian syndrome are predisposed to type 2 diabetes or develop cardiovascular disease . Factors implicated in the low fertility in these patients include anovulation, increased risk of early miscarriage, and late obstetric complications.

The diagnostic criteria of the syndrome were revised by the Rotterdam European Society for Human Reproduction/American Society of Reproductive Medicine (ASRM), where the following criteria were established: oligo/amenorrhea, clinical and biochemical signs of hyperandrogenism, and sonographically confirmed Polycystic ovarian syndrome. . Diagnostic criteria for Rotterdam diagnosis of polycystic ovary syndrome

Two of the following three criteria are required:

  • Oligo/Anovulation
  • Hyperandrogenism
  • Clinical (hirsutism or less commonly male pattern alopecia) or
  • Biochemical (raised FAI or free testosterone)
  • Polycystic ovaries on ultrasound Other aetiologies must be excluded such as congenital adrenal hyperplasia, androgen secreting tumours, Cushing syndrome, thyroid dysfunction and hyperprolactinaemia Sonographic features of Polycystic ovarian syndrome include the presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter and/or increased ovarian volume (>10 mL). This is regardless of follicle distribution or ovarian stromal echogenicity. One ovary fulfilling this definition is sufficient to define Polycystic ovarian syndrome.

Hirsutism is often classified in terms of the distribution and degree of hair growth, such as through pictorial scales. The most widely recognized scoring method is the Ferriman-Gallwey scale.

The Ferriman-Gallwey scale for hirsutism. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.

In a Cochrane Database Systematic Review article, Treatment options for polycystic ovary syndrome, It's mentioned about Alternative medicine and Polycystic ovarian syndrome. Alternative medicine has been emerging as one of the commonly practiced medicines for different health problems. Alternative medicines include many modalities, such as kinesiology, herbalism, homeopathy, reflexology, acupressure, acupuncture, and massage therapy.

Homoeopathy can be defined as a system of drug therapeutics based on the law of similars.Polycystic ovarian syndrome has a specific set of problems which need an individualistic approach.The concept of individualization takes into consideration the total response of the individual to unfavourable environment. This total response is seen through signs and symptoms on three planes: emotional, intellectual and physical where the life force manifests itself.The teachings of Dr Samuel Hahnemann(founder of homoeopathy)-that the human being is a unit -mind, body and spirit and that these are so correlated as to act freely and without any impediment when the vital principle, the spirit like force or dynamis is in equilibrium; yet if this equilibrium of health be thrown out of balance by the dysfunction of one member the whole is affected to a greater or less degree.Homoeopathy is the dominant option to treat Polycystic Ovarian Syndrome. Homoeopathic approach towards management of Polycystic ovarian syndrome is constitutional taking into account the patient's physical symptoms along with their mental and genetic makeup that individualizes the person. Early intervention with Homoeopathy can assist in preventing further progress and hence deterioration caused by Polycystic ovarian syndrome .

Homoeopathic constitutional treatment will help balance hyperactivity of the glands, regulate hormonal balance, dissolve the cysts in the ovaries and force them to resume normal functioning. Homoeopathic medicines will not upset the balance of endocrine secretions ,for the similimum(indicated remedy) will fill the demands of the system in all its parts without stimulating too much those organs which have maintained a relatively secure balance, in other words our remedies affect directly the vital energy which in itself establishes equilibrium. All the homoeopathic polycrest remedies (deep acting with a wide sphere of action) will yield richly to our search for effective remedies in endocrine disorders.Hence, Homoeopathic medicines can restore hormonal balance, normal ovulation, menstrual cycles, and also eliminate the need for hormone therapies and surgery. This can significantly increase the chances of conception. The different expressions of this disease can be managed effectively, safely and gently with Homoeopathic remedies.

Homoeopathy works towards nature. All homeopathy medicines are proved in human beings. It is very refined. It comforts modern living. The medicines have no negative side-effects. They are safe, effective and easy to attain cure. By taking homoeopathy medicines, ovulation and regular menses can be attained in a natural way.

Yogic life style, a form of holistic mind-body medicine, is known to reduce stress and sympathetic tone. Recent randomized controlled trial found holistic yoga program for 12 weeks to be significantly better than physical exercise in reducing Anti-Mullerian Hormone, Luteinizing Hormone and Testosterone, Modified Ferriman and Gallway (mFG) score for hirsutism and improving menstrual frequencies in Polycystic ovarian syndrome patients. Yoga not only addresses the problems of Polycystic ovarian syndrome but is likely to prevent the long term complications such as Cardio-vascular diseases, diabetes.

Following yogic practices are found to be useful in Polycystic ovarian syndrome :

  1. Physical postures (Asanas - 1 min each):
  2. Surya Namaskara (Sun Salutation) for 10 min [5 rounds];
  3. Prone asanas:
  • Cobra Pose (Bhujangasana),
  • Locust Pose (Salabhasana),
  • Bow Pose (Dhanurasana)
  1. Standing asanas:
  • Triangle Pose (Trikonasana),
  • Twisted Angle Pose (Parsva -konasana),
  • Spread Leg Intense Stretch (Prasarita padottanasana),
  1. Supine asanas -
  • Inverted Pose (Viparita Karni),
  • Shoulder Stand (Sarvangasana),
  • Plough Pose (Halasana);
  1. Sitting asanas
  • Sitting forward Stretch (Paschimottanasana),
  • Fixed angle Pose (Baddha- konasana),
  • Garland Pose (Malasana)
  1. Breathing Techniques (Pranayama - 2 min each):
  • Sectional Breathing (Vibhagiya- Pranayama),
  • Forceful Exhalation (Kapalabhati),
  • Right Nostril Breathing (Suryanuloma Viloma) 2 min,
  • Alternate nostril breathing (Nadishuddhi)
  1. Guided relaxation (Savasana) for 10 min
  2. OM Meditation (OM Dhyana) for 10 min
  3. Group Lecture: Lectures, in the form of cognitive restructuring based on the spiritual philosophy underlying yogic concepts, spiritual coping strategies.

Homoeopathic medicines and yoga therapy being holistic approaches might effectively treat the complexity of the symptomatology in Polycystic ovarian syndrome.

Being tested
Homoeopathic Remedies
Keywords
Homoeopathy, Yoga
Medical subject headings
Menstruation Disturbances, Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Homoeopathic RemediesOther

    Also called Homoeopathic remedies and yoga therapy

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

Study groups in NCT03579303
Study groupRoleWhat they receive
Homoeopathic remedies in PCOSActive comparatorHomoeopathic treatment for menstrual disorders in females with PCOS
Receives: Other: Homoeopathic Remedies
Homoeopathic remedies and yoga in PCOSActive comparatorHomoeopathic treatment integrated with yoga therapy for menstrual disorders in females with PCOS
Receives: Other: Homoeopathic Remedies

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3yrs

Secondary outcomes (1)
  1. To assess reduction in hyperandrogenism

    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

    Measured: 3yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study startOct 2018 (estimated)
  3. Primary completion15 Apr 2021 (estimated)
  4. Study completion15 Oct 2021 (estimated)

Resources

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
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03579303
Sponsor's protocol ID
AJP123
Status last verified
Jul 2018
First submitted
6 Jun 2018
Last updated
9 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available .

Publications

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

    PubMed 20011085
  • 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.

    PubMed 21339935
  • 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.

    PubMed 2723060
  • 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.

    PubMed 22808940

Questions about this trial

What is this clinical trial studying?

A study testing Homoeopathic Remedies in people with Menstrual Disorders and Polycystic Ovary Syndrome, 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 3 inclusion and 5 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 9 Jul 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.

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 Dr Anita Lobo, MD HOM (9342436337 ext. 0824-2203902, dr_anitablany@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess if the interventions can facilitate regular menstrual cycle. (time frame: 3yrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579303, which also lists 4 linked publications.

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 9 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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