Effectiveness of Aqueous Extract(Tea) of Euphorbia Hirta (Dudhiya) in Improving Sleep Quality
Condition: Poor Sleep Quality
Study type: Interventional

Summary: 
      Sound sleep is needed for our overall health and optimum our productivity. Sleep quality
      affects people's work performance, mood, safety, and quality of life. Changing times and
      advancements in technology couples with altered lifestyles have taken a toll on human health.
      Poor sleep quality reduces short-term memory, cognitive abilities, and motor skills for all
      age groups. The high prevalence of poor sleep quality in every age group has triggered a
      growing worldwide demand for a safe, effective and easily available herbal cure. Studies
      shown that, E. hirta has sedative action. For this, I hypothesized that oral intake of
      aqueous extract (tea) of E.hirta is efficacious in improving sleep quality.

      In this study I assessed the efficacy of aqueous extract (tea) of Euphorbia hirta (Dudhiya)
      in improving sleep quality in persons aged 20 to 50 years with self-reported sleep
      disturbance.

      The main objective of the study is to assess the efficacy of oral intake of aqueous extract
      of E.hirta in improving sleep quality in terms of having regular sound sleep and freshness in
      the daytime work.

      A total of 32 adults with poor sleep quality was recruited for this study and included both
      of male and female.

      Duration of the study was 05 months and active participation of each participant was 2
      consecutive weeks or 14 days.

      Study area was included Dhaka, Narayanganj and Munshiganj districts and study center was Dr.
      Hakeem Md. Yousuf Harun Bhuiyan Hospital, Hamdard University Bangladesh.
    

Detailed description: 
      Background:

      Sound sleep is needed for our overall health and optimum our productivity. Sleep quality
      affects people's work performance, mood, safety, and quality of life. Changing times and
      advancements in technology couples with altered lifestyles have taken a toll on human health.
      Poor sleep quality reduces short-term memory, cognitive abilities, and motor skills for all
      age groups. The high prevalence of poor sleep quality in every age group has triggered a
      growing worldwide demand for a safe, effective and easily available herbal cure.

      Therefore, in this study I assessed the efficacy of aqueous extract (tea) of Euphorbia hirta
      (Dudhiya) in improving sleep quality in persons aged 20 to 50 years with self-reported sleep
      disturbance.

      Objective of the Study:

      The main objective of the study is to assess the efficacy of oral intake of aqueous
      extract(Tea) of E.hirta compared with placebo (PBO) in improving sleep quality in terms of
      having regular sound sleep and freshness in the daytime work.

      Sample Size:

      Literature review have shown that sample size were included 24, 25, , 60, 112, 165 and 258
      participants in sleep disorder related study. However, prior study on Withania somnifera in
      insomnia and anxiety has shown that the mean of the Pittsburgh Sleep Quality Index at the
      baseline was 13.08 and Standard Deviation (SD) 1.51, post-treatment & after follow up it was
      9.15 and SD 1.8372. Based on this mean and SD, the estimated enrollment of 5 per treatment
      group among those with poor sleep would provide the study with a statistical power of 95% (α
      = 0.05) and confidence interval of 95% to detect significant improvements in sleep quality.
      By using OpenEpi online calculator, my required sample size is 10. Due to chance of loss to
      follow up and placebo effect (5%), my inflated sample size is total number of 32 participants
      which is three times larger than estimated sample size.

      Duration of Study:

      Duration of study for each participant was 05 months days with "day one advertisement" for
      screening followed by randomization for the treatment. The duration of the active
      participation of each participant 2 consecutive weeks or 14 days.

      Study area was included Dhaka, Narayanganj and Munshiganj districts and study centre was Dr.
      Hakeem Md. Yousuf Harun Bhuiyan Hospital, Hamdard University Bangladesh.

      Methods:

      Participants was recruited by using online and printed advertisement of the study.
      Advertisements was posted on the online page of dept. of public health as well as other
      faculties of Hamdard University Bangladesh. Printed advertisement was posted on notice board
      of different faculties of Hamdard University Bangladesh along with providing in-person.
      Advertisements was also posted on online social networking platforms (such as Facebook,
      Facebook groups, LinkedIn). The relevant study requirements with an email address and phone
      number was included in the advertisement.

      Interested respondent was contact to the investigator, and he/she was invited to come to Dr.
      Hakeem Md. Yousuf Harun Bhuiyan Hospital, Hamdard University Bangladesh for assessing sleep
      quality by self-reported Pittsburgh Sleep Quality Index questionnaire and checking physical
      parameters (i.e. general appearance, height, weight, body mass index (BMI), pulse rate, body
      temperature, blood pressure and respiratory rate) as well. Participants who met eligible
      criteria along with Pittsburgh Sleep Quality Index (PSQI) global score equal or greater than
      6, and above mentioned physical parameters were normal -enrolled in this study.

      After enrollment, they were randomized (by third party) into two groups to receive either the
      intervention or the placebo for 2 consecutive weeks or 14 days. A Sleep Diary also provided
      to each participants and instructed to complete it every morning within one hour after wake
      up. Participants were got reminder for taking intervention tea and completing sleep diary
      regularly every 2/3 days interval.

      After completing intervention period, Participants were fulfilled another Pittsburgh Sleep
      Quality Index questionnaire for post-intervention assessment, and also fulfilled Sleep Diary
      was collected.

      The Pittsburgh Sleep Quality Index contains seven component scores are, where the total score
      ranges from 0 to 21 points (0-3 points for each component). Lower scores indicate better
      sleep status. The global score is also calculated, with scores > 5 used to classify
      participants as "poor sleepers" and scores ≤5 used to classify participants as "good
      sleepers".

      The outcome measure will be assessed by the differences between pre and post-intervention
      Pittsburgh Sleep Quality Index global score as well as the percentage reduction in Pittsburgh
      Sleep Quality Index compared with placebo.

      To evaluate Subjective Sleep Efficiency (sSE) during the period of oral intake of aqueous
      extract of the intervention or placebo from sleep diary.

      An intention-to-treat analysis will be conducted for patients who have received intervention
      at least once. Data will be presented as mean±SD and percentage of reduction in the change of
      improving sleep quality with a 95% confidence interval and p=0.05. sSE also be evaluated as
      percentage. Difference between two means will be compared with independent two sample t-test.

      Efficacy Assessment:

        1. Difference of baseline and post intervention mean by PSQI compared with PBO

        2. Comparison of sSE between 1st and 14th day of intervention period from sleep diary

        3. Assess the % of reduction of PSQI global score

      Data and Safety Monitoring:

      To maintain the quality of this trial, data & safety monitoring will be conducted by Data &
      Safety Monitoring Board (DSMB). The members of the DSMB was included that individual who was
      not involved directly in this research. For this clinical trial, DSMB members was joined from
      the Faculty of Unani and Ayurvedic Medicine of Hamdard University Bangladesh.

      Safety Assessment:

      Safety assessment was obtained from the incidence and type of adverse events during study
      period.
    

Intervention name(s): Euphorbia hirta (Dudhiya); PBO(Combined powder of Terminalia arjuna and Terminalia bellerica)
Intervention type(s): Other; Other
Intervention description(s): Duration of the intervention was 2 consecutive weeks or 14 days. In each evening, one teaspoon full (3gm) powder should be mixed with two cups of water and boiled. When it becomes half(one cup), have to add one teaspoon of sugar and drink it as tea.; Duration of the intervention was 2 consecutive weeks or 14 days. In each evening, one teaspoon full (3gm) powder should be mixed with two cups of water and boiled. When it becomes half(one cup), have to add one teaspoon of sugar and drink it as tea.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Sleep; Quality; Herbal; Euphorbia hirta; Dudhiya; Randomized