Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women

NCT ID: NCT05804149

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-30
• Study Completion Date: 2023-02-12

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.

Conditions

Primary Hypothyroidism; Acupuncture; Irregular Menstruation; PCO

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

study group

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: DEVICE

study group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.

Thyroxine

Intervention Type: DRUG

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

low caloric diet

Intervention Type: DIETARY_SUPPLEMENT

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.

control group

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.

Group Type: OTHER

Thyroxine

Intervention Type: DRUG

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

low caloric diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

acupuncture

study group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.

Intervention Type: DEVICE

Thyroxine

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: DRUG

low caloric diet

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: DIETARY_SUPPLEMENT

Other Intervention Names

levothyroxine

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Sedky

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eman Sedky

Cairo, Maadi, Egypt

Countries

Egypt

Other Identifiers

No:P.T.REC/012/002825

Identifier Type: -

Identifier Source: org_study_id