A clinical study to evaluate and compare the effect of Trayodashanga Guggulu and Svayambhuva Guggulu with Laksha Guggulu along with Panchatiktaksheerabasti in the management of Asthikshaya.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To Know the effects of intervention on BMD t score and Laxana of Asthikshaya
研究概览
简要总结
Asthikshaya is Explained in Astadasha Kshaya by Acharya Charaka. Asthikshaya symptoms described in different Samhita are Asthibheda,Asthishoola, Kesha, loma,nakha, smashrudanta vikara, Sandhishaithilya and rukshata. As explaination of Asthikshaya is Analogous with description of Osteopenia and Osteoporosis in contemporary science and often reffered as the Silent Disease. It is considered as serious disabling disease of public health concer. Osteoporosis is disease the second most common metabolic bone and aslo degenerative disease that leads to an increased risk of fractures,but only a small proportion are diagnosed and treated. Modern drugs used for the treatment and have serious adverse effects.Hence there is a need of better and safe cost effective management of Asthikshaya, thus Study is "A CLINICALl STUDY TO EVALUATE AND COMPARE THE EFFECT OF TRAYODASHANGA GUGGULU AND SVAYAMBHUVA GUGGULU WITH LAKSHA GUGGULU ALONG WITH PANCHATIKTAKSHEERABASTI IN THE MANAGEMENT OG ASTHIKSHAYA."
HYPOTHESIS- Total no of subject..........120
Group A....(Lakshaguggulu with Panchatiktaksheerabasti) 40 subjects
Group B....( Trayodashangaguggulu with Panchatiktaksheerabasti) 40 subjects
Group c.....( svayambhuvaguggulu with Panchatiktaksheerabasti ) 40 subjects
Null Hypothesis - H0 - Group B and Group C are not having significant effect than Group A
Alternative Hypothesis-H1- Group B and Group C are having significant effect than Group A
Alternative Hypothesis- H2- Group B has Significant effect more than Group A
Alternative Hypothesis-H3- Group C has Significant effect more than the Group A.
VALUES.. 40+40+40= 120 is the Subjective values in the study.
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
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects complaining of classical symptoms of Asthikshaya- Asthishoola,Sandhishoola, Keshapatana, Dantavikara,Nakhavikara and Osteoporosis-Backpain,Jointpain will be included.
- •Subjects between the age group of 40-70years of either sex.
- •Subjects of Osteopenia and Osteoporosis diagnosed by Bone Mineral Density test.
- •Subjects with BMD score below -1(minus).
- •Subjects fit for Basti Karma.(scheduled treatment protocol).
排除标准
- •Subjects associated with Hypertension, Diabetic mellitus and other systemic disorders.
- •Subjects associated with Secondary Osteoporosis.
- •Pregnant women and lactating women.
- •Subjects with one or more fragility fracture.
结局指标
主要结局
To Know the effects of intervention on BMD t score and Laxana of Asthikshaya
时间窗: base line -36th day-66th day-96th day
次要结局
- To evaluate if the Asthikshaya condition is reversible based on subject parameters like Asthishoola,sandhishoola,keshapatana,nakhadantapatana through Bastikarma & Shamanoushadhi.(To standardize the safe & effective ayurvedic line of management in asthikshaya in comparison to established drug in contemporary medicine based on subject parameters like Asthishoola,sandhishoola,keshapatana,nakhadantapatana.)
研究者
Dr Sharanamma
Shri DGM Ayurvedic Medical College and Hospital Gadag