Effectiveness of Aqueous Extract(Tea) of Euphorbia Hirta (Dudhiya) in Improving Sleep Quality

NCT04930848 | Completed DMC

• 1 other identifier: HUBREC/2021/09/01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poor Sleep Quality

Keywords

Sleep; Quality; Herbal; Euphorbia hirta; Dudhiya; Randomized

Outcome Measures

Primary Outcomes (2)

• Change in the Pittsburgh Sleep Quality Index global score. It's total score ranges from 0 to 21. The global score > 5 used to classify participants as "poor sleepers" and scores ≤5 used to classify participants as "good sleepers".

  Difference of baseline and post intervention mean by the Pittsburgh Sleep Quality Index compared with placebo. Difference between two means will be compared with independent two sample t-test. Assess the % of reduction of Pittsburgh Sleep Quality Index global score, Baseline to 14 days.

  14 days

• Change in Subjective sleep efficiency(sSE)

  Comparison of Subjective sleep efficiency(sSE) between 1st and 14th day of intervention period from sleep diary.

  14 days

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Euphorbia hirta

Other: Euphorbia hirta (Dudhiya)

Placebo Arm

PLACEBO COMPARATOR

Terminalia arjuna and Terminalia bellerica

Other: PBO(Combined powder of Terminalia arjuna and Terminalia bellerica)

Interventions

Euphorbia hirta (Dudhiya) OTHER

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.

Intervention Arm

PBO(Combined powder of Terminalia arjuna and Terminalia bellerica) OTHER

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.

Placebo Arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female age 20 to 50 years old
• Having poor sleep quality (the PSQI global score ≥6) according to preliminary sleep assessment
• Self-reported no problems with communication, both visual and auditory (reading, writing, hearing and speaking)
• Signed the voluntary informed consent form for the clinical trial
• Live in Dhaka, Narayanganj or Munshiganj district.

You may not qualify if:

• Has taken western and/or oriental medicine and/or therapy and/or dietary supplements in the past 2 weeks for sleep disorders such as insomnia before the preliminary screening
• Has a severe neural or psychiatric disorder or a history of major neuropsychiatric disorder e.g. autism, learning disorder, and mental retardation
• Has a hemorrhagic disease or anticoagulant intake
• Has a serious physical disorder i.e. heart disease, diabetes, cancer etc
• Has participated in any other clinical trial within a month of the screening date
• Pregnancy and lactation

Sponsors & Collaborators

• Dr. Zannatun Nahar Nuri: lead

Study Sites (1)

Hamdard University Bangladesh

Munshiganj, 1510, Bangladesh

Location

Study Officials

• Zannatun N Nuri, BAMS

  MPH student, Hamdard University Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: April 3, 2021
• Primary Completion: April 27, 2021
• Study Completion: May 10, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting 6 months after publication.
• Access Criteria: Request by email.

Locations

BA (1)