Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317064
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2024-02-23
Brief Title:
Diagnostic and Therapeutic Potential of Substance P NK1R Receptor in Primary Dysmenorrhea
Sponsor:
Lahore Medical Research Center LLP
Organization:
Lahore Medical Research Center LLP
Study Overview
Official Title:
Diagnostic and Therapeutic Potential of Substance P NK1R Receptor in Primary Dysmenorrhea A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dysmenorrhea is characterized as excruciating menstrual cramps of uterine origin and is one of the most prevalent gynecological illnesses Substance P SP and NK1R mediate the symptoms of various pain disorders with chronic andor neuropathic pain Objective To evaluate diagnostic and therapeutic potential of Substance P NK1R receptor in primary dysmenorrhea Study Design This was a randomized controlled trial which took place at Lahore Medical Research Center from April 2023 to August 2023 Non-probability convenient sampling techniques was used for sampling A total of 40 female participants was included in the study who met specific criteria for inclusion The study comprised of three phases Phase 1 Before medication Phase 2 NSAIDs and Phase 3Dexamethasone Aprepitant 10 females with no dysmenorrhea participated as controls The study duration spanned three menstrual cycles 20 dysmenhorric and 6 controls were analyzed for NK1R levels Several assessment tools were also used in the study
Detailed Description:
This was a randomized controlled trial which took place at Lahore Medical Research Center from April 2023 to August 2023 Non-probability convenient sampling techniques was used for sampling A total of 40 female participants was included in the study who met specific criteria for inclusion 10 females with no dysmenorrhea participated as controls The study duration spanned three menstrual cycles during which participants were divided into three Phases Phase 1 Blood samples of all 30 patients were collected prior to any medication Phase 2 All 30 participants in this phase used NSAIDs Non-steroidal Anti-Inflammatory Drugs during their dysmenorrhea period Phase 3 All the patients from phase 2 n30 received NK1R antagonist Dexamethasone 6mg Aprepitant 80mg for 2 days Out of these patients 20 dysmenhorric and 6 controls were analyzed for NK1R levels
Data Collection
A 5cc blood sample was collected from each participant on the 2nd day of their menstrual cycle before any intervention Another 5cc blood sample was collected on the 2nd day of the menstrual cycle after the first intervention Another 5cc blood sample was collected on the 2nd day of the menstrual cycle after the 2nd intervention Prior to and following the intervention a complete blood count CBC was conducted to assess any changes in blood parameters Serum was extracted from the collected blood samples for further analysis
Human SP and Neurokinin-1 Receptor NK1R levels measurement Human SP and its antagonist NK1R levels were analyzed using ELISA technique This analysis was performed thrice to investigate the role of Substance P and NK1R in menstrual pain before and after the intervention BT Lab Human Substance P and NK1R ELISA kit was used to measure levels of SP and NK1R in serum samples of participants Catalogue Numbers E1528Hu E6938Hu
Assessment tools
The studys participants filled out a basic questionnaire meant to collect sociodemographic information and analyze a variety of parameters Body Mass Index BMI Family History of Pain Age at Menarche Length of Menstrual Cycle Age of Onset of Dysmenorrhea and Sleep Duration were all included in these surveys The Depression Anxiety Stress Scale DASS Visual Analogue Scale VAS Mini Nutritional Assessment MNA International Physical Activity Questionnaire IPAQ and Pictorial Blood Loss Assessment Chart were among the other questionnaires used
Visual Analogue Scale VAS
Female participants levels of pain were measured using the Visual Analog Scale VAS With a scale from 0 to 10 where 10 is the most excruciating pain possible the VAS is a well-known measure for assessing pain perception Participants were divided into three groups to reflect varied levels of pain severity based on their VAS ratings obtained throughout the first three consecutive days of both menstrual cycles Mild Pain Moderate Pain and Severe Pain
Mini Nutritional Assessment MNA
The female participants eating patterns were assessed using the Nestle Nutrition Institute Mini Nutritional Assessment in order to look into any possible associations between their diet and menstrual discomfort Participants who scored between 24 and 30 had good nutritional status those who scored from 17 to 235 were at risk of malnutrition and those who scored under 17 were poorly nourished
Depression Anxiety Stress Scale DASS-21
The DASS-21 was used to evaluate the psychological health of our subjects and comprehend how it related to dysmenorrhea Based on their stated levels of stress anxiety and depression participants were divided into five groups using this scale normal mild moderate severe and extremely severe A score of 0 to 9 indicates normal 10 to 13 indicates mild depression 14 to 20 indicates moderate depression 21 to 27 indicates severe depression and 28 or above indicates extremely severe depression Scores between 0 and 7 indicate normal anxiety 8 to 9 indicate mild anxiety 10 to 14 indicate moderate anxiety 15 to 19 indicate severe anxiety and 20 or more indicate extremely severe anxiety For stress 0-14 represents normal 15-18 represents mild 19-25 represents moderate 26-33 represents severe and 34 represents really severe stress
Pictorial Blood Loss Assessment Chart PBAC
The Pictorial Blood Loss Assessment Chart PBAC a self-administered pictorial assessment chart that assigns scores based on how much tampons and cotton-based sanitary pads stain throughout a menstrual cycle was given to the patients as a tool to measure their menstrual blood volume 24-26 Reliability of the PBAC has been shown 25 26 They were given guidelines by the researcher on how to utilize the PBAC Hypomenorrhea was linked to PBAC scores of 10 or less regular monthly flow was linked to PBAC scores of 10 to 99 and heavy menstrual bleeding was linked to PBAC scores of 100 or more for two months Cotton pads were the only sanitary goods used Software for statistical analysis was used to determine scores
Statistical Analysis
Data analysis was carried out using Graph Pad Prism 802 a statistical software package The collected data including questionnaire responses CBC results Substance P and NK1R levels were analyzed to assess the effects of the interventions on menstrual pain and related factors Two-way ANOVA test was used for analysis P-value less than 005 was considered significant
Ethical considerations
This study was approved by Ethical Review Board of Lahore Medical Research Center The research followed declaration of Helsinki and written and informed consent was taken from all participants
Data Collection
A 5cc blood sample was collected from each participant on the 2nd day of their menstrual cycle before any intervention Another 5cc blood sample was collected on the 2nd day of the menstrual cycle after the first intervention Another 5cc blood sample was collected on the 2nd day of the menstrual cycle after the 2nd intervention Prior to and following the intervention a complete blood count CBC was conducted to assess any changes in blood parameters Serum was extracted from the collected blood samples for further analysis
Human SP and Neurokinin-1 Receptor NK1R levels measurement Human SP and its antagonist NK1R levels were analyzed using ELISA technique This analysis was performed thrice to investigate the role of Substance P and NK1R in menstrual pain before and after the intervention BT Lab Human Substance P and NK1R ELISA kit was used to measure levels of SP and NK1R in serum samples of participants Catalogue Numbers E1528Hu E6938Hu
Assessment tools
The studys participants filled out a basic questionnaire meant to collect sociodemographic information and analyze a variety of parameters Body Mass Index BMI Family History of Pain Age at Menarche Length of Menstrual Cycle Age of Onset of Dysmenorrhea and Sleep Duration were all included in these surveys The Depression Anxiety Stress Scale DASS Visual Analogue Scale VAS Mini Nutritional Assessment MNA International Physical Activity Questionnaire IPAQ and Pictorial Blood Loss Assessment Chart were among the other questionnaires used
Visual Analogue Scale VAS
Female participants levels of pain were measured using the Visual Analog Scale VAS With a scale from 0 to 10 where 10 is the most excruciating pain possible the VAS is a well-known measure for assessing pain perception Participants were divided into three groups to reflect varied levels of pain severity based on their VAS ratings obtained throughout the first three consecutive days of both menstrual cycles Mild Pain Moderate Pain and Severe Pain
Mini Nutritional Assessment MNA
The female participants eating patterns were assessed using the Nestle Nutrition Institute Mini Nutritional Assessment in order to look into any possible associations between their diet and menstrual discomfort Participants who scored between 24 and 30 had good nutritional status those who scored from 17 to 235 were at risk of malnutrition and those who scored under 17 were poorly nourished
Depression Anxiety Stress Scale DASS-21
The DASS-21 was used to evaluate the psychological health of our subjects and comprehend how it related to dysmenorrhea Based on their stated levels of stress anxiety and depression participants were divided into five groups using this scale normal mild moderate severe and extremely severe A score of 0 to 9 indicates normal 10 to 13 indicates mild depression 14 to 20 indicates moderate depression 21 to 27 indicates severe depression and 28 or above indicates extremely severe depression Scores between 0 and 7 indicate normal anxiety 8 to 9 indicate mild anxiety 10 to 14 indicate moderate anxiety 15 to 19 indicate severe anxiety and 20 or more indicate extremely severe anxiety For stress 0-14 represents normal 15-18 represents mild 19-25 represents moderate 26-33 represents severe and 34 represents really severe stress
Pictorial Blood Loss Assessment Chart PBAC
The Pictorial Blood Loss Assessment Chart PBAC a self-administered pictorial assessment chart that assigns scores based on how much tampons and cotton-based sanitary pads stain throughout a menstrual cycle was given to the patients as a tool to measure their menstrual blood volume 24-26 Reliability of the PBAC has been shown 25 26 They were given guidelines by the researcher on how to utilize the PBAC Hypomenorrhea was linked to PBAC scores of 10 or less regular monthly flow was linked to PBAC scores of 10 to 99 and heavy menstrual bleeding was linked to PBAC scores of 100 or more for two months Cotton pads were the only sanitary goods used Software for statistical analysis was used to determine scores
Statistical Analysis
Data analysis was carried out using Graph Pad Prism 802 a statistical software package The collected data including questionnaire responses CBC results Substance P and NK1R levels were analyzed to assess the effects of the interventions on menstrual pain and related factors Two-way ANOVA test was used for analysis P-value less than 005 was considered significant
Ethical considerations
This study was approved by Ethical Review Board of Lahore Medical Research Center The research followed declaration of Helsinki and written and informed consent was taken from all participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None