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临床试验/CTRI/2020/09/027735
CTRI/2020/09/027735已完成2 期

Evaluation of kala basti protocol with Patoladi-ksheera niruha basti and ksheerabala thaila anuvasana basti in Osteoporosis

KLE University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年7月12日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
10
试验地点
1
主要终点
1)REDUCTION IN PAIN- Assessed using Visual analogue scale and using grading for tenderness

研究概览

简要总结

WHO defines Osteoporosis as “a progressive systemic disease, characterized by low bone density and micro-architectural deterioration in bone that predisposes patients to increased bone fragility and fracturesâ€.According to recent statistics from the International Osteoporosis Foundation, worldwide, 1 in 3 women over the age of 50 years and 1 in 5 men will experience osteoporotic fractures in their lifetime. Every fracture is a sign of another impending one. Moreover, osteoporosis results in a decreased quality of life, increased disability-adjusted life span, and big financial burden to health insurance systems of countries that are responsible for the care of such patients. With an early diagnosis of this disease before fractures occur and by assessing the bone mineral density and with early treatment, osteoporosis can be prevented. It is also important to recognize that the ideal drugs for the treatment of osteoporosis or other bone disorders have yet to be developed. Drugs or therapies which are inexpensive, yet effective with minimal side effects are need of the hour. They must encompass effectiveness to prevent fractures and disease deformities in the enormous number of individuals who will are and will be at risk of bone disease as the population ages. 

Asthi is considered as one among the sapta dhatus and the whole body is dependent on asthi for dharana or stability. Kala is defined as ‘Dhatvashayantara Maryada’ i.e. membranous structure which separates or limits Dhatus and Ashayas. Treatment which is having an effect on kala helps to maintain the normal functioning of the dhatu which is related to it. Pureesha dhara kala/pakwasaya is same as that of asthi dhara kala. Pakwashaya is the vishesha sthana of vataVata and asthi are having asraya asryi bhava in a reciprocal way, increase in vata leads to asthi kshayaBasthi which is considered as ardhachikitsa, act on pakwashaya, thus for diseases of asthi dhatu caused by vata dosha, basti is said to be the primary choice of treatment. Treatment of Asthigata Vikaras is explained as*; Basti* with Ksheera and Ghritha processed with Tikta Dravyas .Patoladi ksheera basti is having tikta dravyas like patola ,arishta , ushira , chaturangula, hribera, rohini, tikta, madana and other drugs like sthira, bala, madhuka, ksheera which are balya, rasayana, and vata shamaka.

       

Initially subjects diagnosed with osteoporosis are screened according to the inclusion and exclusion criteria. Selected patients are  posted for basti line of management for 16 days. Till the next follow up which is on 48th day the subject is given with placebo(starch filled capsule) to keep the subject in touch with the study.

Followup will be done on the 16th and 48th day .

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

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

入选标准

  • 1.Patients between the age group of 35-65 years of either sex.
  • 2.Patients of Osteoporosis diagnosed by B.M.D test (t-score-2.5 and below).
  • 3.Patients complaining of classical symptoms of Asthikshaya like joint pain, pain in the bones etc.
  • 4.Patient fit for Basti Karma.

排除标准

  • 1.Patients with endocrine disorders (Hyperthyroidism,hyperparathyroidism, Untreated Cushing syndrome) 2.Patients suffering from pathological Osteoporosis and neoplasms of the bone.
  • 3.Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction.
  • 4.Patients suffering from Mal-absorption syndrome.
  • 5.Patients undergone Organ transplantation or on immunosuppressive therapy.
  • 6.Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout , SLE, Psoriatic arthritis.

结局指标

主要结局

1)REDUCTION IN PAIN- Assessed using Visual analogue scale and using grading for tenderness

时间窗: 16th and 48th day

3)Changes in serum calcium and alkaline phosphatase

时间窗: 16th and 48th day

2)REDUCED GENERAL DEBILITY- assessed using grading for general debility

时间窗: 16th and 48th day

次要结局

  • improved quality of life in patients with osteoporosis assessed by Medical Outcomes Survey 36-item short form questionnaire (SF-36)(48th day)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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