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Impact of Ginger on Menopausal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Menopause Dietary Supplement: Zingiber Officinale powder Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Official Title: Impact of Zingiber Officinale on Symptoms and Hormonal Changes During the Menopausal Period in Duhok -Iraq
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : March 1, 2022
Actual Study Completion Date : June 1, 2022

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Arms and Interventions
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Arm Intervention/treatment
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)

 Dietary Supplement: Zingiber Officinale powder
Ginger powder
Other Name: Ginger
Placebo Comparator: Control group (Placebo)
All the participants were given starch powder (50 mg) capsules twice daily for twelve weeks.
 Dietary Supplement: Placebo
Starch powder
Other Name: control


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05499793


Locations
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Iraq
University of Duhok College of Pharmacy
Duhok, Kurdistan Region, Iraq, 42001
Sponsors and Collaborators
University of Duhok
More Information
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Responsible Party: Niroosh Hashim Taha, MSc Student in clinical Pharmacology, University of Duhok
ClinicalTrials.gov Identifier: NCT05499793    
Other Study ID Numbers: 24102021-10-36
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The collected Data will not be shared until the study has been published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No