Primary HypothyroidismPhase 2NCT05804149
Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
A Phase 2 study testing acupuncture, Thyroxine and low caloric diet in people with Primary Hypothyroidism and Acupuncture, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Primary Hypothyroidism, Acupuncture, Irregular Menstruation
- What is being tested?
- acupuncture, Thyroxine and low caloric diet
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2020to 12 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- acupuncture, Thyroxine, low caloric diet
- Keywords
- primary hypothyroidism, acupuncture, low caloric diet, infertile women
- Medical subject headings
- Hypothyroidism, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
study group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months.
ThyroxineDrug
Also called levothyroxine
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 dietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | 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 Receives: Device: acupuncture; Drug: Thyroxine; Dietary Supplement: low caloric diet |
| control group | Other | 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. Receives: Drug: Thyroxine; Dietary Supplement: low caloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from TSH at 4 months.
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.
Measured: change from FT4 at 4 months.
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).
Measured: change from BMI at 4 months.
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.
Measured: change LH at 4 months.
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.
Measured: change from FSH at 4 months.
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
Measured: change from PCOS Questionnaire at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start30 Aug 2020
- Primary completion25 Sep 2022
- Study completion12 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypothyroidismStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Sedky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804149
- Sponsor's protocol ID
- No:P.T.REC/012/002825
- Status last verified
- Mar 2023
- First submitted
- 16 Feb 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture and Low Caloric Diet on Primary Hypothyroidism and Irregular Menstruation in Infertile Women
- ClinicalTrials.gov ID
- NCT05804149
- Acronym / sponsor ID
- No:P.T.REC/012/002825
- Conditions
- Primary Hypothyroidism, Acupuncture, Irregular Menstruation, PCO
- Keywords
- primary hypothyroidism, acupuncture, low caloric diet, infertile women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: acupuncture, Drug: Thyroxine, Dietary Supplement: low caloric dietEach 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 |
| control group | Other | Drug: Thyroxine, Dietary Supplement: low caloric dietEach 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupuncturestudy group take acupuncture Acupuncture was applied with a total duration of 35-45 minutes, 2 sessions per week for 4 months. | Device | study group |
| ThyroxineAlso: levothyroxineEach 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 | Drug | control group, study group |
| low caloric dietEach 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. | Dietary supplement | control group, study group |
Primary outcome
Thyroid hormones (TSH). (mu/l)
Time frame: change from TSH at 4 months.
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)
Time frame: change from FT4 at 4 months.
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).
Time frame: change from BMI at 4 months.
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)
Time frame: change LH at 4 months.
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)
Time frame: change from FSH at 4 months.
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)
Time frame: change from PCOS Questionnaire at 4 months.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture, Thyroxine and low caloric diet in people with Primary Hypothyroidism and Acupuncture, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid hormones (TSH). (mu/l) (time frame: change from TSH at 4 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.