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Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT03713138
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Farhat Younas, Allied Hospital Faisalabad

Brief Summary:

The study was conducted to determine the therapeutic role of flax seed for Poly cystic ovary syndrome. A sample of 100 subjects were collected. The subjects were from various age group ranging from 18 to 45 years. Subjects showing the signs, symptoms, biochemical, and clinical parameters of the diseases were included in the study. Three different quantities of flax seed were introduced to the subjects for 90 days.

Objectives:

  1. To assess the nutritional status of Poly cystic Ovary Syndrome patients
  2. To determine the therapeutic role of flax seed for PCOS patients

Material and method: The level of follicle stimulating hormone, leutinizing hormone, sex hormone binding globulin, serum prolactin, ultrasound were analyzed. To determine the side effects of the flax seed, the liver-enzymatic, lipid profile, and renal tests were conducted.


Condition or disease Intervention/treatment Phase
Poly Cystic Ovary Syndrome Dietary Supplement: flaxseed powder Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled placebo trial
Masking: Single (Participant)
Masking Description: Single-blinded trial, Intervention and placebo given
Primary Purpose: Treatment
Official Title: Therapeutic Role of Flax Seed for Poly Cystic Ovary Syndrome
Actual Study Start Date : March 23, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Flaxseed powder

Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.

Intervention/ Dietary Supplement:

Flax seed powder

Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.

Other Name: intervention

Dietary Supplement: flaxseed powder
Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.
Other Name: Intervention

No Intervention: Control group; Comparison group

The controlled group was given no intervention. No intervention was done to this group.

Three different quantities of white flour were intervened to the subjects. One group was given 15 grams of white flour a day. Second group was given 20 grams and third group was given 25 grams of white flour a day.




Primary Outcome Measures :
  1. Follicle stimulating hormone (mIU/MI) [ Time Frame: 3 months ]
    The blood sample was taken to determine the quantitative level of serum follicles stimulating hormone (FSH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA).

  2. Leutinizing Hormone (mIU/MI) [ Time Frame: 3 months ]
    The blood sample was taken to determine the quantitative level of serum luteinizing hormone (LH) in patients fed with flaxseed powder by following the Immuno-enzymatic calorimetric method (ELISA-ALPCO)

  3. Sex hormone binding globulin (mg/dL) [ Time Frame: 3 months ]
    The serum sex hormone binding globulin hormone (SHBG) in patients fed with flaxseed powder was determined by following the Rosner's method.

  4. Serum Prolactin (ng/ml) [ Time Frame: 3 months ]
    The serum sex prolactin level in patients fed with flaxseed powder was determined by following the radio-immunological method.


Secondary Outcome Measures :
  1. blood sugar fasting (mg/dL) [ Time Frame: 3 months ]
    The blood sample was taken to check the fasting blood glucose level. The sample was taken eight hours after eating. Fasting blood glucose level as determined by glucose dye oxido-reductase mediator reaction which is specific for glucose by glucometer Accuchek active

  2. Thyroid stimulating hormone (Ml/L) [ Time Frame: 3 months ]
    The thyroid stimulating hormone (TSH) level in patients fed with flaxseed powder was performed to determine the thyroid gland functioning by following the third-generation non-isotopic method.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • All females of age 18 to 45 having PCOS

    • Women showing the presence of two out of three features (Oligo- or anovulation, hyper-androgenism, or polycystic ovaries (Ovarian volume >10cc, 12 or more peripherally located follicles 2-9 mm in diameter or hypo-echoic enlarged ovaries with hyper-echoic central stroma in USG)
    • Patients on Metformin (used for insulin resistance)

Exclusion Criteria:

  • • Females under 18 and above 45 years of age

    • Those on any other medical therapy
    • Pregnant and lactating women
    • Those with a history of allergy to flaxseed
    • Women on antiplatelet and fibrinolytic drugs
    • Women showing signs of PCOS but showing normal ovaries on ultrasound

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713138


Locations
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Pakistan
Allama Iqbal Open University
Islamabad, Punjab, Pakistan, 45710
Sponsors and Collaborators
Allied Hospital Faisalabad
Investigators
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Study Director: Khalid Mahmood, MPhill Akuwat

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Responsible Party: Farhat Younas, Clinical Nutritionist, Allied Hospital Faisalabad
ClinicalTrials.gov Identifier: NCT03713138     History of Changes
Other Study ID Numbers: 6099
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Farhat Younas, Allied Hospital Faisalabad:
Follicle stimulating hormone
Leutinizing hormone
Sex hormone binding globulin
Serum Prolactin
Flaxseed sachets
Lipid profile

Additional relevant MeSH terms:
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Syndrome
Ovarian Cysts
Disease
Pathologic Processes
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases