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The Impact of vitamin B12 supplementation on the efficacy of conventional drug in the management of pcos patient

prevalence of vitamin B12 deficiency among Indian women with poly cystic ovary syndrome (PCOS) and the impact of vitamin B12 supplementation on the efficacy of conventional drugs in the management of women with pcos - PCOS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014570
Enrollment
240
Registered
2018-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- patient will get vitamin B 12 supplement along with standard medications

Interventions

Intervention1: vitamin B12 supplementation: Vitamin B12 supplementation will be given in combination with either metformin, pioglitazone or spironolactone to the selected three groups Control Interven

Sponsors

AIIMS Research Section
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The details of menstrual history will include age of menarche ,regularity,duration,dysamenorrhea,flow and number of menstrual cycles per year.The history of weight gain, obesity, infertility,unwanted hair growth,acne vulgaris,etc will be recorded as per a prediagnosed performa. A pedigree will be made to note family history of hirusitism, infertility, hypertention,menstrual disorders,known diabetes mellitus or glucose intolerence, CAD and obesity at least in three generations. The diagnosis of PCOS will be based on the presence of two out of three following features with the exclusion of other etiologies of androgen excess and anovulatory infertility. these features include. 1.clinical/ biochemical science of androgenism 2.oligo or chronic anovulation. 3. polycysitic ovaries on transabdominal ultrasonography.

Exclusion criteria

Exclusion criteria: Diabetes mellitus/Hypertension/COPD / chronic lung disease/ Hypothyriod Pregnancy and lactation Drugs (steroids, lithium, NSAIDs, ACE inhibitors, statins) Patients who refuse consent

Design outcomes

Primary

MeasureTime frame
a) To compare biochemical and hormonal parameters between vegetarian and non vegetarian (b) To compare Clinical parameters (menstrual cycles, hirsutism score, testosterone levels) after treatment with levothyroxine and life style modification. (c) to evaluate the impact of vit-B 12 supplementation on the efficacy of conventional drugs in the management of women with PCOSTimepoint: 0,3 and 6 months—

Secondary

MeasureTime frame
prevelance of vitamin B12 deficiency in PCOS patientsTimepoint: 24 Weeks—

Countries

India

Contacts

Public ContactDr Mohd Ashraf Ganie

All India Institute Of medical sciences

ashraf.endo@gmail.com9968856888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026