NCT05804149

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2020-08-30
• Primary completion: 2022-09-25
• Completion: 2023-02-12
• First posted: 2023-04-07
• Last updated: 2023-04-07

Locations

1 site across 1 country: Egypt