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临床试验/CTRI/2022/07/044274
CTRI/2022/07/044274尚未招募不适用

An Open, Non-Randomized, Single Arm, Single Centric Clinical Trial To Evaluate The Effectiveness Of Pala (Citramutti) Madakku Thailam In The Management Of Asthi Vatham (Osteoporosis) Among Out-Patients Attending Ayothidoss Pandithar Hospital, National Institute Of Siddha

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
The outcome of the study will be assessed by using the

研究概览

简要总结

Introduction:

This is an open Non Randomised clinical trial thatevaluates therapeutic effectiveness of siddha formulation Pala (Citramutti)Madakku Thailam in the management of Asthi vatham (Osteoporosis)patients through improvement of T scores in Bone Mineral Densitometer Scanbefore and after treatment. Worldwide,it is estimated that 1 in 3 women above the age of 50 will experienceosteoporotic fractures, as well as 1 in 5 men. According to the Siddha, Asthivatham (Osteoporosis) can betreated using the trial drug. The major ingredient Sida cordifolia werefound to be effective in increasing the bone density in patients with  osteoporosis in several studies. It also hasrich source of phytoestrogens which inhibit bone resorption and negate the boneresorption effects. Milk is an excellent calcium source and also suppresses thebone resorption in Osteoporosis. Sesamum indicum also exhibits pro-osteoblasticand anti-osteoclastic activity.

Objective: To evaluate the therapeutic effectiveness of Pala(Citramutti) Madakku Thailam in the management of Asthivatham (Osteoporosis) usingT scores of Bone Mineral Densitometer Scan before and after treatment.

Materials and Methods: An Open Non Randomised Clinical Trial witha total of 10 patients diagnosed of Asthi vatham (Osteoporosis) with ageof above 40 years willing to participate in the study ,by signing the informedconsent form will be enrolled in the study. The trial drug will be given for 90days along with 1 month follow up.

Result: The average T scores before and after treatment will be statisticallyanalysed.

Keywords: PalaMadakku Thailam, Osteoporosis

研究设计

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

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Bone Mineral Density T-Score less than – 1 will be included.

排除标准

  • K/H/O Renal / Hepatic / cardiac disease
  • K/H/O Prolonged glucocorticoid administration
  • K/H/O Genetic or autoimmune disorders
  • All cases of Secondary Osteoporosis including K/H/O Cushing’s syndrome, K/H/O Hyperparathyroidism.

结局指标

主要结局

The outcome of the study will be assessed by using the

时间窗: Screening - 2 months | Enrolment - 2 months | Intervention - 4 months | Data Analysis - 2 months | Follow up - 2 months

1. Bone Mineral Density Scan (Peripheral DXA Scan) T Score before and after treatment.

时间窗: Screening - 2 months | Enrolment - 2 months | Intervention - 4 months | Data Analysis - 2 months | Follow up - 2 months

2. Improvement in Clinical symptoms before and after treatment.

时间窗: Screening - 2 months | Enrolment - 2 months | Intervention - 4 months | Data Analysis - 2 months | Follow up - 2 months

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital

研究点 (1)

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