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Related Concept Videos

Group Design02:01

Group Design

The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between the two are due to...
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Multiple Comparison Tests

Multiple comparison test, abbreviated as MCT, is a post hoc analysis generally performed after comparing multiple samples with one or more tests. An MCT will help identify a significantly different sample among multiple samples or a factor among multiple factors.
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Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Experimental Designs01:16

Experimental Designs

An experimental design is a systematic process that allows researchers to evaluate the relationship between dependent and independent variables. There are three widely used types of experimental design - pre-experimental design, true experimental design, and quasi-experimental design. In pre-experimental design, the researcher compares the data before and after some interventions or treatments. The true-experimental design has more than one purposefully created group, a commonly measured...
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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to subjects...
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Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...

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Ayurvedic Management of Presbycusis (Project TOPMAC): Protocol for an Exploratory Randomized Controlled Trial.

Krishna Kumar V1, Sanjeev V Thomas2, Murugan C Nair2

  • 1Central Council for Research in Ayurvedic Sciences, New Delhi, India.

JMIR Research Protocols
|September 23, 2024
PubMed
Summary

This study investigates TOPMAC, an Ayurvedic intervention, for managing age-related hearing loss (presbycusis). Early results suggest potential benefits for tinnitus, hearing, and cognitive function, paving the way for further research.

Keywords:
AyurvedaKarnapuranaKshirabala TailaRasayanaTOPMACWithania somnifera (L.) Dunalage-related hearing lossauditory informationcognitive deteriorationeffectivenessefficacygeriatricshearing losshearing statusinterventionolder adultolder adultspopulation-basedpresbycusissensorineuraltinnitustopical oil pooling

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Area of Science:

  • Integrative Medicine
  • Gerontology
  • Audiology

Background:

  • Presbycusis, or age-related hearing loss, affects over 50% of adults over 75, often with tinnitus and cognitive decline.
  • Current treatments focus on quality of life, lacking restorative options.
  • Ayurveda offers traditional treatments like Karnapurana (topical oil pooling) for hearing and cognitive issues.

Purpose of the Study:

  • To evaluate the efficacy of TOPMAC (Topical Oil Pooling with Kshirabala Taila and Ashwagandha Churna supplementation) in managing presbycusis.
  • To assess TOPMAC's impact on tinnitus suppression, hearing function, and cognitive protection in patients aged 60-75.
  • To explore TOPMAC as a potential integrative approach for presbycusis management.

Main Methods:

  • An exploratory, parallel-group, randomized controlled trial involving 60 participants with mild to moderate presbycusis.
  • Participants randomized to receive either basic treatment and health education (BTHE) or BTHE plus TOPMAC for 24 weeks.
  • Primary outcome: hearing function protection; Secondary outcomes: tinnitus suppression and cognitive function protection.

Main Results:

  • The study commenced in January 2023, with ethics committee approvals obtained.
  • Patient enrollment began in September 2023, with 22 participants enrolled as of August 2024.
  • Data analysis is pending; results are anticipated by January 2025.

Conclusions:

  • If effective, this trial will support a definitive study on TOPMAC's role in presbycusis management.
  • TOPMAC could be a cost-effective integrative therapy for age-related hearing loss.
  • Potential integration with India's National Program for Prevention and Control of Deafness.