A Randomized Controlled Trial To Evaluate The Efficacy Of Panchtikta Ksheer Basti And Bisphosphonates On Bone Resorption Marker CTX-1 In The Management Of Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Osteoporosis is a chronic skeletal disorder characterized by low bone mass, deterioration of bone microarchitecture, and increased risk of fragility fractures. It is often referred to as a silent disease because bone loss occurs gradually without obvious symptoms until fractures occur. In Ayurveda Asthi- majja kshaya presents sign and symptoms that closely parallel to osteoporosis are asthishula, toda, sandhi shaithilya, kesha, loma, nakha, danta vikara, daurbalya, rukshata sparshashyatava.
Drug- 1. Bisphosphonates- 70mg weekly once through oral route purchased from Litnow Lifescience near pull bazar Narnaul.
- Tikta ksheer Basti- 480 ml should be administered through rectal route for 15 days in 1st cycle and next 15 days in 2nd cycle prepared in BKNGAC & H.
Research Question: Does Tikta Ksheer Basti produce greater reduction in bone resorption marker serum CTX-I in osteoporosis.
Null Hypothesis: There is no significant difference between Tikta Ksheer Basti and Bisphosphonate on bone resorption marker serum CTX-I in osteoporosis.
Alternate Hypothesis: There is significant difference between Tikta Ksheer Basti and Bisphophonate on bone resorption marker serum CTX-I in osteoporosis.
Subjective Criteria- Detailed performa of Lakshans of Asthi Kshaya
Detailed performa of Lakshans of Vata Vriddhi.
Objective Criteria- i) BMI (ii) CTX-I (iii) VAS Scale (iv) KNOOS Score (v) MRI If required (vi) Waist hip circumference
Expected Outcome -Anyone among Null and Alternate hypothesis will be outcome
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
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patient representing with classical features of Asthikshaya 2 Patient of both sexes are taken 3 Patient of osteoporosis diagnosed by biomarker CTX-I (C-terminal cross linked telopeptide) 4 Willingness to provide written informed consent and comply with study protocol 5 Patients fit for Basti.
排除标准
- •1 Patient below the age of 30 and above 60 years 2 Patient suffering from any systemic disorder like DM, HTN, Endocrinal disorders, Paget’s disease, Cushing syndrome etc 3 Patient suffering from pathological osteoporosis or any neoplasm or osteoporosis related to systemic disorders 4 Osteoporosis associated with fracture 5 Patients who were unfit for Basti karma.
研究者
DrRavina
The Institute of Ayurved studies & Research
