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临床试验/CTRI/2024/05/067945
CTRI/2024/05/067945招募中2/3 期

A Randomized Clinical Study On Efficacy Of Anuvasna Basti With Special Reference To Musculoskeletal Pain In Premenopausal Postmenopausal Phase

National Institute Of Ayurveda1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
120
试验地点
1
主要终点
Changes in Numerical Rating Scale (NRS) for pain

研究概览

简要总结

Pain is described as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage" by the International Association for the Study of Pain (IASP). Acute or persistent pain that affects the bones, muscles, ligaments, tendons, and even nerves is referred to as musculoskeletal pain (MSP), and it is a widespread medical and socioeconomic issue across the world. Joint and musculoskeletal problems can cause pain, which is a significant symptom that can lead to function loss. As a result, it may be employed as a prognostic and/or therapeutic indication of the illness state and is indicative of the severity and activity of the underlying medical condition. Musculoskeletal pain is prevalent and places a significant strain on individuals as well as social and healthcare institutions, impacting both sexes, people of all ages, and people from all socioeconomic backgrounds. Musculoskeletal pain is becoming more common, and it has been called an epidemic. According to the World Health Organization (WHO), 20–33% of the world’s population has some form of chronic musculoskeletal pain, translating to 1.75 billion people globally.

Perimenopause is a state during which women are particularly predisposed to develop MSP. As to moderate to severe degrees of MSP, the odds increase linearly with age, from pre-menopause to peri- and then to post-menopause. The estimated overall prevalence of MSP among perimenopausal women was 7.1%.

Commonly practiced treatment for MSP includes, NSAIDS, COX-2 inhibitors and corticosteroid injections. Above said NSAIDS etc. provide short term relief from pain but their extended use over a period of time has various adverse effects such as MI, atrial fibrillation, acute renal dysfunction, GI bleeding etc. time

**Research****Question:**Is Anuvasna Basti effective in Sarvangavata with special reference to musculoskeletal pain in perimenopausal/postmenopausal phase.

**Hypothesis:**Anuvasna Basti is not effectivein Sarvangavata with special reference to musculoskeletal pain in perimenopausal/postmenopausal phase.

**NullHypothesis(H0):**Anuvasna Basti is effective in Sarvangavata with special reference to musculoskeletal pain in perimenopausal/postmenopausal phase.

 **Aim:**The aim of the study is to explore a short-term intervention which may be repeated frequently to arrest the MSP in peri and post-menopausal phase of women.

Objective****of the **study:**To evaluate the change in Numerical rating score (NRS) for musculoskeletal pain.To evaluate the change in quality of life in peri and post-menopausal phase of women.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • 1.Female with classical sign and symptoms of Sarvangavata.
  • 2.Females in perimenopausal/postmenopausal phase.
  • 3.Patient willing and able to participate in this study for entire trial period with informed consent.
  • 4.Patient fit for Anuvasna Basti karm.
  • 5.Patients with a washout period of 15 days, who have been taking medication or panchakarma therapy for same condition.
  • 6.Females between the age of 35 to 65 years.

排除标准

  • XCLUSION CRITERIA 1.Patient, suffering from any acute or chronic debilitating disease (conditions involving cardiac, vascular, hematological, respiratory, hepatic, gastrointestinal, renal functions, endocrinal, central nervous system.
  • or psychiatric disorder or active cancer) and having other serious pathology.
  • 2.Patients with long term steroid treatment.

结局指标

主要结局

Changes in Numerical Rating Scale (NRS) for pain

时间窗: 30th day from baseline in each arm.

次要结局

  • Changes in EuroQol-5-Dimension.(30th day from baseline in each arm.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Richa Dwivedi

National Institute Of Ayurveda

研究点 (1)

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