Back to resultsEffect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
Primary Purpose
Primary Hypothyroidism, Acupuncture, Irregular Menstruation
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
acupuncture
Thyroxine
low caloric diet
Sponsored by
About this trial
This is an interventional supportive care trial for Primary Hypothyroidism focused on measuring primary hypothyroidism, acupuncture, low caloric diet, infertile women
Eligibility Criteria
Inclusion Criteria: Sixty PCOS women will be evaluated for presence of hirsutism, acne, irregular menses. They will be diagnosed for presence of cysts by Ultrasonography apparatus. They will complain from primary hypothyroidism. Their thyroid-stimulating hormone (TSH) will be >4.0mu/l and free tetraiodothyronine (FT4) will be <0.8ng/dl. Their luteinizing hormone / follicle-stimulating hormone (LH/FSH) ratio will be <1. Their age will range from 20-35 years old. Their body mass index (BMI) will be > 25 kg/m2 and < 39.9 kg/m2. Exclusion Criteria: History of previous neurological disorders, previous thyroidectomy, and surgical removal of uterus. Presence of hemorrhage, carcinoma, metal implants and using of immune suppressant drugs. Presence of endometriosis, uterine fibroids, primary ovary insufficiency, fallopian tube damage or blockage, pelvic adhesion, autoimmune disorders, implantation failure, and infections.
Sites / Locations
- Eman Sedky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
study group
control group
Arm Description
Each patient in the study group will be instructed about the beneficial effect of the acupuncture. Each woman in the study group will assume side lying position with uncovered treatment area, thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine. low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. Fine sterile needles will be used with a size 0.25x25mm. They will be inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles will be used in the treatment
Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine Each woman in both groups will follow a low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. The regime will start with 1200 Kcal for the first month and 1100 for the second month then 900 Kcal for the third month until reach 800 Kcal in fourth month.
Outcomes
Primary Outcome Measures
Thyroid hormones (TSH). (mu/l)
60 participants with hypothyroidism assessed by blood analysis for thyroid hormones to measure percentage of improvement of hypothyroidism. ELISA plate reader used to measure thyroid hormones including (TSH) measured by mu/l, before starting and after the end of the study course.
Thyroid hormones (FT4). (ng/dl)
60 participants with hypothyroidism assessed by blood analysis for thyroid hormones to measure percentage of improvement of hypothyroidism. ELISA plate reader used to measure thyroid hormones including (FT4) measured by ng/dl, before starting and after the end of the study course.
BMI (kg/m2).
60 infertile women with hypothyroidism assessed by Weight-Height scale. to measure weight (kg) and height (cm) to calculate BMI at starting and after the end of the study course. BMI will be calculated according to the formula: BMI=Weight/Height square (kg/m2).
reproductive hormones including LH(IU/L)
60 participants with hypothyroidism assessed by blood analysis for reproductive hormones to measure percentage of improvement of infertility (PCOS). ELISA plate reader used to measure (LH) measured by (IU/L) before starting and after the end of the study course.
FSH (mIU/mL)
60 participants with hypothyroidism assessed by blood analysis for reproductive hormones to measure percentage of improvement of infertility (PCOS). ELISA plate reader used to measure (FSH) measured by (mIU/mL), before starting and after the end of the study course.
Health-Related Quality-of-Life (PCOS Questionnaire) (score from 26:182 units on scale)
60 participants infertile women assessed by Health-Related Quality-of-Life Questionnaire (PCOSQ) to asses health and health related quality of life issues including emotion, body hair, weight, infertility problems, and menstrual problems for each woman in both control and study groups before starting and after the end of the study course. Score from 26:182 units on scale as questionnaire consists of 26 questions, foreach question, there is seven rating options. heigh score means more improvement, while low score means less improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05804149
Brief Title
Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
Official Title
Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 30, 2020 (Actual)
Primary Completion Date
September 25, 2022 (Actual)
Study Completion Date
February 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the goal of this randomize clinical trial is to compare in 60 infertile women with hypothyroidism. selected from national Nutritional institute out clinic. the main question it aims to answer is:
• There an effect of acupuncture and low caloric diet on primary hypothyroidism and irregular menstruation in infertile women.
all participants were received• thyroxine tablets (levothyroxine) • a low caloric diet regime.
researchers compared study group (30 infertile women with hypothyroidism) to see the effect of acupuncture sections on hypothyroidism.
Detailed Description
Each woman was instructed carefully about the assessment and treatment procedures and a consent form has been signed by each woman before starting of this study,
Each patient in the study group was instructed about the beneficial effect of the Acupuncture.
Each woman in the study group assumed supine position for the points (DU20, GB20, ST9, LI4, RN6, RN4, SP9, ST36, SP6, KI3, LR2). and prone position for DU14, BL15, BL20, BL23, DU4 with uncovered treatment area, which was cleaned with alcohol and hair was removed.
Acupuncture was applied on a room temperature of 37. Fine sterile needles used with a size 0.25x25mm. They were inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles were used in the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypothyroidism, Acupuncture, Irregular Menstruation, PCO
Keywords
primary hypothyroidism, acupuncture, low caloric diet, infertile women
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine Acupuncture will be applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Each patient in the study group will be instructed about the beneficial effect of the acupuncture.
Each woman in the study group will assume side lying position with uncovered treatment area,
thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine.
low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months.
Fine sterile needles will be used with a size 0.25x25mm. They will be inserted to various depths (2-5 cm) at acupoints points on the body according to site and fat deposition. 16 needles will be used in the treatment
Arm Title
control group
Arm Type
Other
Arm Description
Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine Each woman in both groups will follow a low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. The regime will start with 1200 Kcal for the first month and 1100 for the second month then 900 Kcal for the third month until reach 800 Kcal in fourth month.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
study group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.
Intervention Type
Drug
Intervention Name(s)
Thyroxine
Other Intervention Name(s)
levothyroxine
Intervention Description
Each woman in both groups (control and study) will receive thyroxine tablets (levothyroxine) (1tablet per day) describe by the physician. Levothyroxine is usually taken 30-60 minutes before breakfast, or four hours after food, as certain substance such as food and calcium can inhabit the absorption of levothyroxine
Intervention Type
Dietary Supplement
Intervention Name(s)
low caloric diet
Intervention Description
Each woman in both groups will follow a low caloric diet regime consisting of 1200 to 800Kcal/ day for 4 months. The regime will start with 1200 Kcal for the first month and 1100 for the second month then 900 Kcal for the third month until reach 800 Kcal in fourth month.
Primary Outcome Measure Information:
Title
Thyroid hormones (TSH). (mu/l)
Description
60 participants with hypothyroidism assessed by blood analysis for thyroid hormones to measure percentage of improvement of hypothyroidism. ELISA plate reader used to measure thyroid hormones including (TSH) measured by mu/l, before starting and after the end of the study course.
Time Frame
change from TSH at 4 months.
Title
Thyroid hormones (FT4). (ng/dl)
Description
60 participants with hypothyroidism assessed by blood analysis for thyroid hormones to measure percentage of improvement of hypothyroidism. ELISA plate reader used to measure thyroid hormones including (FT4) measured by ng/dl, before starting and after the end of the study course.
Time Frame
change from FT4 at 4 months.
Title
BMI (kg/m2).
Description
60 infertile women with hypothyroidism assessed by Weight-Height scale. to measure weight (kg) and height (cm) to calculate BMI at starting and after the end of the study course. BMI will be calculated according to the formula: BMI=Weight/Height square (kg/m2).
Time Frame
change from BMI at 4 months.
Title
reproductive hormones including LH(IU/L)
Description
60 participants with hypothyroidism assessed by blood analysis for reproductive hormones to measure percentage of improvement of infertility (PCOS). ELISA plate reader used to measure (LH) measured by (IU/L) before starting and after the end of the study course.
Time Frame
change LH at 4 months.
Title
FSH (mIU/mL)
Description
60 participants with hypothyroidism assessed by blood analysis for reproductive hormones to measure percentage of improvement of infertility (PCOS). ELISA plate reader used to measure (FSH) measured by (mIU/mL), before starting and after the end of the study course.
Time Frame
change from FSH at 4 months.
Title
Health-Related Quality-of-Life (PCOS Questionnaire) (score from 26:182 units on scale)
Description
60 participants infertile women assessed by Health-Related Quality-of-Life Questionnaire (PCOSQ) to asses health and health related quality of life issues including emotion, body hair, weight, infertility problems, and menstrual problems for each woman in both control and study groups before starting and after the end of the study course. Score from 26:182 units on scale as questionnaire consists of 26 questions, foreach question, there is seven rating options. heigh score means more improvement, while low score means less improvement
Time Frame
change from PCOS Questionnaire at 4 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sixty PCOS women will be evaluated for presence of hirsutism, acne, irregular menses. They will be diagnosed for presence of cysts by Ultrasonography apparatus.
They will complain from primary hypothyroidism. Their thyroid-stimulating hormone (TSH) will be >4.0mu/l and free tetraiodothyronine (FT4) will be <0.8ng/dl.
Their luteinizing hormone / follicle-stimulating hormone (LH/FSH) ratio will be <1.
Their age will range from 20-35 years old.
Their body mass index (BMI) will be > 25 kg/m2 and < 39.9 kg/m2.
Exclusion Criteria:
History of previous neurological disorders, previous thyroidectomy, and surgical removal of uterus.
Presence of hemorrhage, carcinoma, metal implants and using of immune suppressant drugs.
Presence of endometriosis, uterine fibroids, primary ovary insufficiency, fallopian tube damage or blockage, pelvic adhesion, autoimmune disorders, implantation failure, and infections.
Facility Information:
Facility Name
Eman Sedky
City
Cairo
State/Province
Maadi
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
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