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.
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
- Conditions the study is for
- Menstrual Disorders, Polycystic Ovary Syndrome
- 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
- 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
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 :
- Physical postures (Asanas - 1 min each):
- Surya Namaskara (Sun Salutation) for 10 min [5 rounds];
- Prone asanas:
- Cobra Pose (Bhujangasana),
- Locust Pose (Salabhasana),
- Bow Pose (Dhanurasana)
- Standing asanas:
- Triangle Pose (Trikonasana),
- Twisted Angle Pose (Parsva -konasana),
- Spread Leg Intense Stretch (Prasarita padottanasana),
- Supine asanas -
- Inverted Pose (Viparita Karni),
- Shoulder Stand (Sarvangasana),
- Plough Pose (Halasana);
- Sitting asanas
- Sitting forward Stretch (Paschimottanasana),
- Fixed angle Pose (Baddha- konasana),
- Garland Pose (Malasana)
- Breathing Techniques (Pranayama - 2 min each):
- Sectional Breathing (Vibhagiya- Pranayama),
- Forceful Exhalation (Kapalabhati),
- Right Nostril Breathing (Suryanuloma Viloma) 2 min,
- Alternate nostril breathing (Nadishuddhi)
- Guided relaxation (Savasana) for 10 min
- OM Meditation (OM Dhyana) for 10 min
- 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.
- Conditions
- Menstrual Disorders, Polycystic Ovary 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 group | Role | What they receive |
|---|---|---|
| Homoeopathic remedies in PCOS | Active comparator | Homoeopathic treatment for menstrual disorders in females with PCOS Receives: Other: Homoeopathic Remedies |
| Homoeopathic remedies and yoga in PCOS | Active comparator | Homoeopathic 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.
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)
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.
- First posted6 Jul 2018
- Study startOct 2018 (estimated)
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Menstrual DisordersStudies 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
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fr Muller Homoeopathic Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anita Fernandes, Fr Muller Homoeopathic Medical College
- Investigators
- Dr. Subramanya Pailoor, Ph.D., Study chair, Central University of Kerala, Kasaragod,Dr Prema D'Cunha, MD,DNB, Study chair, Father Muller Medical college,Kankanady,Mangalore
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 20011085Badawy 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 21339935Bern 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 2723060Nidhi 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03579303
- Acronym / sponsor ID
- AJP123
- Conditions
- Menstrual Disorders, Polycystic Ovary Syndrome
- Keywords
- Homoeopathy, Yoga
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Fr Muller Homoeopathic Medical CollegeUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
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.
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 :
- Physical postures (Asanas - 1 min each):
- Surya Namaskara (Sun Salutation) for 10 min [5 rounds];
- Prone asanas:
- Cobra Pose (Bhujangasana),
- Locust Pose (Salabhasana),
- Bow Pose (Dhanurasana)
- Standing asanas:
- Triangle Pose (Trikonasana),
- Twisted Angle Pose (Parsva -konasana),
- Spread Leg Intense Stretch (Prasarita padottanasana),
- Supine asanas -
- Inverted Pose (Viparita Karni),
- Shoulder Stand (Sarvangasana),
- Plough Pose (Halasana);
- Sitting asanas
- Sitting forward Stretch (Paschimottanasana),
- Fixed angle Pose (Baddha- konasana),
- Garland Pose (Malasana)
- Breathing Techniques (Pranayama - 2 min each):
- Sectional Breathing (Vibhagiya- Pranayama),
- Forceful Exhalation (Kapalabhati),
- Right Nostril Breathing (Suryanuloma Viloma) 2 min,
- Alternate nostril breathing (Nadishuddhi)
- Guided relaxation (Savasana) for 10 min
- OM Meditation (OM Dhyana) for 10 min
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homoeopathic remedies in PCOS | Active comparator | Other: Homoeopathic RemediesHomoeopathic treatment for menstrual disorders in females with PCOS |
| Homoeopathic remedies and yoga in PCOS | Active comparator | Other: Homoeopathic RemediesHomoeopathic treatment integrated with yoga therapy for menstrual disorders in females with PCOS |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
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 RemediesAlso: Homoeopathic remedies and yoga therapycomparison between homoeopathic treatment and integrated approach of homoeopathy and yoga in menstrual disorders of females with PCOS | Other | Homoeopathic remedies and yoga in PCOS, Homoeopathic remedies in PCOS |
Primary outcome
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
1 secondary outcome
To assess reduction in hyperandrogenism
Time frame: 3yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Results publication: PubMed 20011085Prapas N, Karkanaki A, Prapas I, Kalogiannidis I, Katsikis I, Panidis D. Genetics of polycystic ovary syndrome. Hippokratia. 2009 Oct;13(4):216-23.
- Results publication: PubMed 21339935Badawy A, Elnashar A. Treatment options for polycystic ovary syndrome. Int J Womens Health. 2011 Feb 8;3:25-35. doi: 10.2147/IJWH.S11304.
- Results publication: PubMed 2723060Bern 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.
- Results publication: PubMed 22808940Nidhi 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.
- Yoga Exercises for PCOS \| PCOS TreatmentLink provided by the sponsor.
- Boyle J, Teede H J,Polycystic ovary syndrome An update :Volume 41, No.10, October 2012 Pages 752-756.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available .
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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. Subramanya Pailoor, Ph.D. study chair
Central University of Kerala, Kasaragod,
Dr Prema D'Cunha, MD,DNB study chair
Father Muller Medical college,Kankanady,Mangalore
1 site in 1 country: see every site and its status.
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.