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临床试验/CTRI/2024/04/066033
CTRI/2024/04/066033尚未招募不适用

An Analytical Cross-Sectional Study of Asthi Dhatu in pre and post menopausal women with special reference to bone mineral density

National Institute of Ayurveda Deemed to be University Jaipur1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年6月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Assessment of the Bone Mineral Density in premenopausal and postmenopausal women

研究概览

简要总结

NEED OF STUDY:Decreased Bone Mineral Density (BMD) is a major consequence that is associated with feeble, frail and fractured bones .[i]Osteoporosis and its worst outcomes such as fractures and chronic pain are common in both genders, however, women are more vulnerable, accounting for 70–80 percent of all traumas including hip, spine and wrist fractures[ii]. This prevalence increases further in postmenopausal women because of reduced estrogen levels resulting in accelerated loss of bone mass [iii].According to WHO, 30 % of postmenopausal women suffer from osteoporosis. Estrogen deficiency play an important role in development of osteoporosis. So we can say that  postmenopusal  women tend to loose bone      at a rapid rate compared to younger age . [iv]According to WHO diagnostic classification of osteoporosis is defined by BMD. Many evolving clinical factors that influence the risk of osteoporotic changes are  poor exposure of sunlight, nutritional factors specially calcium deficiency, vit D deficiency, postmenopausal hormone mediated metabolic elements and low bone mineral density. The prevalence of osteoporosis is observed four time more common in women than in men.

DXA has become the most widely used method to assess bone mineral density. Important features of DXA that made it popular were easy of use, high precision, and low radiation exposure to the patient. The noninvasive measurement of bone mass in the rat using DXA has proved to be accurate and precise, and DXA has become a primary search tool for the assessment of bone mineral density in an experimental environment. These developments the have inspired a multitude of clinical studies with serial bone mineral density assessment using DXA measurements assess the efficacy of the study medication in preserving or gaining bone mass.[v]

The present study is to assess the status of Asthi Dhatu Sarata in premenopausal stage and postmenopausal stage according to Ayurvedic prespective with special reference to BMD.

AIM:To assess the status of Asthi Dhatu Sarata in premenopausal Group in comparison to postmenopausal  group  with  special reference to Bone Mineral Density.

 OBJECTIVES:Ø  To study the physiology of Asthi Dhatu Sarata

Ø  To study the physiology of Rajah

Ø To assess the Asthi Dhatu Sarata and Bone Mineral Density in  Pre and Post Menopausal women

Ø  To compare the Bone mineral density status in  premenopusal group and post menopausal     group

HYPOTHESIS:

NULL HYPOTHESIS (H0):There is no relation in status of Asthi Dhatu Saratain premenopausal group and post menopausal  group With Special Reference to Bone Mineral Density.

 ALTERNATIVE HYPOTHESIS (H****1):

There is relation in status of Asthi Dhatu Saratain premenopausal group and  postmenopausal group with special reference to Bone Mineral Density .

OUTCOME:PRIMARY OUTCOME:Assessment of the Bone Mineral Density in premenopausal and postmenopausal women

 SECONDARY OUTCOME: Assessment  of the status of Asthi Dhatu  Sarata in premenopausal women and postmenopausal women

METHODOLOGY:

·       **Study Setting:**In and around ofNIA(DU), Jaipur.,

·       Study Population: IPD and OPD patient in NIA(DU) hospital,

·       Period of study:     One and half years

·       Sampling:  Quota sampling.

·       Sample Size– 150 subjects will be  non randomly selected and divided into 2 groups; each group  will be having 75 subjects.

Group A -   75 Premenopausal women selected for this study.

Group B -   75 Postmenopausal women Selected  for this study.

Site of BMD Scan  â€“ Left hip joint bonein both groups .

ASSESSMENT CRITERIA:Subjective Criteria: 1. Asthi Dhatu Sarata[i]

Objective Criteria:

1.Assessment criteria based on BMD .

WHO definitions of osteoporosis based on BMD [i]


[i] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5335887/table/t4-ejr-4-1-46/?report=objectonly


[i] Gunawat CP, Singh G, Patwardhan K, Gehlot S. Weighted mean: A possible method to express overall Dhatu Sarata. J Ayurveda Integr Med. 2015;6(4):286‐289. doi:10.4103/0975-9476.172386


[i] Weaver C.M., Gordon C.M., Janz K.F., Kalkwarf H.J., Lappe J.M., Lewis R., O’Karma M., Wallace T.C., Zemel B.S. The National Osteoporosis Foundation’s position statement on peak bone mass development and lifestyle factors: A systematic review and implementation recommendations. Osteoporos. Int. 2016;27:1281-1386. doi: 10.1007/s00198-015-3440-3. [PMC free article] [PubMed] [CrossRef] [Google Scholar]

[ii] Johnell O., Kanis J.A. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos. Int. 2006;17:1726-1733. doi: 10.1007/s00198-006-0172-4. [PubMed] [CrossRef] [Google scholar}

[iii] Kanis J.A. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: Synopsis of a WHO report. Osteoporos. Int. 1994;4:368-381. doi: 10.1007/BF01622200. [PubMed] [CrossRef] [Google Scholar]

[iv] https://www.ncbi.nlm.ih.gov/pmc/articles/PMC8910053/ text xil  https://www.sciencedirect.com/science/article/pii/S1028455921001388

[v] Hagiwara S, Lane N, Engelke K, et al: Precision and accuracy for rat whole body and femur bone mineral determination with dual x-ray absorptiometry. Bone Miner 22:57, 1993.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Women in the age group of 40-55 years Women in the age group of 40-55 years who are having regular and adequate menstruation will be considered as premenopausal group For postmenopausal group, Only those women will be included who did not had menstrual periods for 1 year.

排除标准

  • K/C/O any systemic disorders (Cardiac disease, hypertension, hyperthyroidism, hypothyroidism, diabetes mellitus.Etc) Women those who are already diagnosed with malignancy.
  • Women with H/o any obstetric surgery like hysterectomy and ovarian surgery Subject on immunosuppressive drugs or steroidal therapy.

结局指标

主要结局

Assessment of the Bone Mineral Density in premenopausal and postmenopausal women

时间窗: 1.5 years

次要结局

  • Assessment of the status of Asthi Dhatu Sarata in premenopausal women and postmenopausal women(1.5 yers)

研究者

发起方
National Institute of Ayurveda Deemed to be University Jaipur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Rubina Bano

Department of Kriya Sharir NIADU Jaipur

研究点 (1)

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