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Completed

NCT Number: NCT05499793

Impact of Ginger on Menopausal Symptoms

This study aimed to examine the impact of one gram of Zingiber Officinale powder on menopausal symptoms since a large number of menopausal women in this region (Duhok city in the North of Iraq) are reluctant to take the conventional treatment for improving their menopausal symptoms and they prefer of taking the ginger powder and surprisingly many of those patients reported positive effects on their symptoms and general well being.

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Key information

Conditions

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Duhok College of Pharmacy

Duhok, Kurdistan Region, 42001, Iraq

About this study

After taking the scientific and ethical approval from the College of the Pharmacy/ University of Duhok and the Directorate of Duhok Health (reference number 24102021-10-36) to look at the impact of Zingiber officinale on menopausal symptoms in women between 45 and 60 years old. A clinical interventional study was launched at the Gynecology Department in Azadi Teaching Hospital in Duhok Governorate, Iraq, from December 2021 to May 2022. This study initially recruited seventy women who matched the inclusion criteria. All the recruited women were informed about the study protocols, and they had the option to withdraw from it anytime. After giving written consent, they were randomly divided into one of two research groups through a random number generator software. Thirty-five women functioned as controls and were given placebo capsules for twelve weeks (A professional pharmacist formulated a 50mg starch purchased from the local market to look similar to the ginger capsule). The other thirty-five women were given pure Zingiber Officinale powder (500mg) in capsules twice daily for twelve weeks (Zingiber Officinale capsules were purchased from Pure Mountain Botanicals, 1712 Pioneer Ave # 1139 Cheyenne Wyoming 82001 (USA)). Twenty women completed the study in the placebo group, while thirty women completed the survey in the Ginger group. Unfortunately, fifteen participants from the control group and five women from the treatment group didn't finish the study and were excluded as they were not tighter to the project protocol.

The frequency and severity of menopausal symptoms were assessed using an internationally recognized questionnaire menopausal rating scale (MRS). Percentage differences between pre-treatment were compared to post-treatments.

The serum estrogen, progesterone, FSH, and LH levels were measured before and after treatment using a suitable kit for each hormone by Cobas e 411 analyzers (Roche Diagnostics).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women living in Duhok city with self-reported menopause symptoms
  • Aged between 45 and 60 years

Exclusion criteria

  • Not on treatment for menopausal symptoms
  • Patients Having chronic diseases like hypertension, Ischemic heart diseases or Diabetes mellitus
  • Patients having coagulopathies
  • Patient's having hormone-dependent malignancies

Treatment and study plan

Zingiber Officinale powder

Dietary Supplement

Ginger powder

Other names: Ginger

Placebo

Dietary Supplement

Starch powder

Other names: control

Primary outcomes

  1. Impact of Zingiber Officinale on hot flush in menopausal women

    Time frame: six weeks treatment with Zingiber Officinale powder

    A significant change in the intensity of hot flushes was observed in the menopausal rating scale in menopausal women treated with ginger powder compared to pre-treatment.

  2. Impact of Zingiber Officinale on Night sweating in menopausal women

    Time frame: six weeks treatment with Zingiber Officinale powder

    A significant change in the intensity of night sweating was observed in the menopausal rating scale in menopausal women treated with ginger powder compared to pre-treatment.

  3. Impact of Zingiber Officinale on estrogen levels in menopausal women

    Time frame: six weeks treatment with Zingiber Officinale powder

    A significant change was observed in serum estrogen levels in menopausal women treated with ginger powder compared to pre-treatment.

  4. Impact of Zingiber Officinale on body weight in menopausal symptoms

    Time frame: six weeks treatment with Zingiber Officinale powder

    A significant change was observed in body weight in kilograms in menopausal women treated with ginger powder compared to pre-treatment.

Sponsors and collaborators

Lead sponsor

University of Duhok

Other

Registry information

Official study title

Impact of Zingiber Officinale on Symptoms and Hormonal Changes During the Menopausal Period in Duhok -Iraq

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2022
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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