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Impact of Ginger on Menopausal Symptoms

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ClinicalTrials.gov Identifier: NCT05499793
Recruitment Status : Completed
First Posted : August 12, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Niroosh Hashim Taha, University of Duhok

Tracking Information
First Submitted Date  ICMJE August 7, 2022
First Posted Date  ICMJE August 12, 2022
Last Update Posted Date August 12, 2022
Actual Study Start Date  ICMJE December 1, 2021
Actual Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Ginger on Menopausal Symptoms
Official Title  ICMJE Impact of Zingiber Officinale on Symptoms and Hormonal Changes During the Menopausal Period in Duhok -Iraq
Brief Summary 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.
Detailed Description

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized clinical trial
Masking: Double (Participant, Investigator)
Masking Description:
A pharmacist professional was responsible for distributing the treatment (ginger) and placebo and he was in charge to assign the participants to the groups.
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE
  • Dietary Supplement: Zingiber Officinale powder
    Ginger powder
    Other Name: Ginger
  • Dietary Supplement: Placebo
    Starch powder
    Other Name: control
Study Arms  ICMJE
  • Experimental: Treatment group (Ginger)

    All the participants were given Zingiber Officinale powder (500 mg) capsules twice daily for twelve weeks.

    Zingiber Officinale capsules were purchased from Pure Mountain Botanicals, 1712 Pioneer Ave # 1139 Cheyenne Wyoming 82001 (USA)

    Intervention: Dietary Supplement: Zingiber Officinale powder
  • Placebo Comparator: Control group (Placebo)
    All the participants were given starch powder (50 mg) capsules twice daily for twelve weeks.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2022)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2022
Actual Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iraq
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05499793
Other Study ID Numbers  ICMJE 24102021-10-36
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The collected Data will not be shared until the study has been published
Current Responsible Party Niroosh Hashim Taha, University of Duhok
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Duhok
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Duhok
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP