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Clinical Trials/CTRI/2024/08/072060
CTRI/2024/08/072060
Not yet recruiting
Phase 2

An Open Label Randomised Comparative Clinical Study- To Evaluate The Combined Effect Of Yoga And Naturopathy Techniques In Polycycstic Ovarian Syndrome(Pcos)

DR. JANHVI GOMARE1 site in 1 country40 target enrollmentStarted: August 21, 2024Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
DR. JANHVI GOMARE
Enrollment
40
Locations
1
Primary Endpoint
REGULARITY OF MENSTRUAL CYCLE AND REDUCTION OF OVARAIN CYST SIZE

Overview

Brief Summary

Polycystic ovarian syndrome or PCOS is a multifactorial and polygenic condition. PCOS is one of the most common Hormonal disorders among women in reproductive age group. The incidence varies between 0.5 to 4% more common amongst infertile women. It is prevalent in young reproductive age group 20 to 30%. Polycystic ovary may be seen in about 20% of normal women1. In this condition, the ovaries of the woman may become enlarged and they may develop numerous harmless fluids filled sacs (follicles). These follicles are underdeveloped sacs which are meant for developing eggs – in PCOS, these follicles fail to release the matured eggs. Following unhealthy Food patterns, sedentary lifestyle, hormonal imbalance, stress and insulin resistance leads to PCOS. Treatment is primarily targeted to correct the biochemical abnormalities, weight reduction, management of hyperandrogenemia, metabolic syndrome, hyperinsulinemia, endometrial hyperplasia, ovulation induction, insulin sensitizers and surgery which is expensive as well as can lead to complications2. The yoga therapy or ‘yoga chikitsa’ refers to the treatment of diseases by means of yogic exercises which may be physical or mental or both. This mode of treatment has been practiced in India from very ancient times. Yoga aims at obtaining relief from pain and suffering. Konasanas are the sets of asanas help to develop and tone the muscles, has favorable effect on the abdominal and pelvic organs as they get compression alternatively and aids good circulation. Naturopathy is the system in which natural elements are used such as panchamahabhuta are used to treat the diseases3. Hydrotherapy is one among the naturopathy treatment which elements the morbid matter and improves the circulation to the organs of the body. It is a need of hour to find out the natural, cost effective and safe methods to treat the PCOS. With this background, the present study is designed to evaluate the combined effect of selected yoga and naturopathy techniques in PCOS.

Group A 20 Subjects and Group B 20 Subjects

Intervention of the study:-

GROUP ASelected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning except during menstruation period.Asanas: - Practicing following asanas 2 rounds each minimum 30 seconds holding in final posture -Parshvakonasana, Parivritta Konasana, Trikonasana, Parivritta Trikonasana, Upavishta Konasana, Suptakonasana, Baddhakonasana.GROUP BSelected Yogasanas will be demonstrated and practiced by the subjects for 3 months every day morning along with Neutral hip bath for 20 minutes everyday evening except during menstruation period.

Assessment schedule:  

subjects are assessed on 0th day, 31st day, 61st day and 91st day.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Age group 18-40 years old females.
  • Subjects diagnosed with PCOS as defined by Rotterdam criteria.

Exclusion Criteria

  • Subjects below 18 years of age and above 40 years old Subjects already on other drug treatment for PCOS like OC Pills etc Subjects with known cases of systemic disorders like hypertension, renal disorders, and metabolic disorders like diabetes mellitus, thyroid dysfunction.
  • Subjects with ovarian fibroids, carcinoma.
  • Pregnant women and lactating mothers Subjects who are not willing to participate in the study.

Outcomes

Primary Outcomes

REGULARITY OF MENSTRUAL CYCLE AND REDUCTION OF OVARAIN CYST SIZE

Time Frame: 31st day and 61st day

Secondary Outcomes

  • Reduction Ferriman-Gallwey Score , BMI (Body mass index), Investigator Global Assessment Of Acne.(31st day, 61st day, 91st day)

Investigators

Sponsor
DR. JANHVI GOMARE
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

DR JANHVI MAHADEV GOMARE

Rajiv Gandhi University Of Health Science , Banglore

Study Sites (1)

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