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临床试验/CTRI/2026/03/106966
CTRI/2026/03/106966尚未招募不适用

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

DrRavina1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5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
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.

  1. 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

发起方
DrRavina
申办方类型
Other [self funding]
责任方
Principal Investigator
主要研究者

DrRavina

The Institute of Ayurved studies & Research

研究点 (1)

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