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临床试验/CTRI/2024/09/073536
CTRI/2024/09/073536已完成2/3 期

Pharmacotherapeutic study to assess the efficacy of Babula Phala ( Fruit of Acacia arabica Willd.) in Asthikshya (osteoporosis)

Government Ayurved Hospital Vadodara1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Asthishula (pain in bone)

研究概览

简要总结

Clinical study has obtained Institutional Ethics committee clearance (GAC/VAD/IEC/90/2024, Date-04/02/2024) and registered at Clinical trial Registry of India ICMR, New Delhi, Vide CTRI/2024/09/073536, [Registered on 06/09/2024]. Study single blind clinical trial. 38 patients were enrolled. Among them 32 patients were completed the study. The overall therapeutic assessment revealed that the treatment produced mild to moderate improvement (34%) in most subjects, with 65.62% showing mild and 6.25% showing moderate improvement, while no complete or marked cure was observed. Among individual symptoms, the maximum improvement was seen in Shrama (39.06%), followed by Asthishula (38.54%). Moderate relief was noted in Rukshata (15.63%) and Nakha Vikara (14.06%). Mild improvement was observed in Asthi Sandhi Baddhata (9.38%) and Sandhi Shaithilya (9.37%), while Keshapatana (5.72%) showed minimal improvement. Additionally, the assessment of objective parameters revealed statistically significant improvement after treatment. Serum Calcium (8.90%) showed a highly significant increase, while Bone Mineral Density – BMD (6.36%) exhibited a significant improvement. Overall, the therapy showed better efficacy in reducing Shrama and Asthishula, indicating that the formulation provided beneficial support in managing the symptoms of Asthikshaya (Osteoporosis).

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • Age group between 40 to 60 years Gender all Patients having 3 or more classical signs & symptoms of Asthikshaya (osteoporosis) as mentioned in diagnostic criteria.
  • BMD (t-score) is less than -1.

排除标准

  • Age less than 40yrs and more than 60yrs.
  • Pregnant women and lactating mother.
  • Patients associated with Autoimmune, metabolic and lifestyle diseases like RA, OA, Skeletal TB, HTN, DM, Hypothyroidism etc.
  • BMD (t-score) is equal or more than -1.

结局指标

主要结局

Asthishula (pain in bone)

时间窗: 8 weeks

Sandhi Shaithilya (looseness or weakness of joints)

时间窗: 8 weeks

次要结局

  • Asthi Sandhi Baddhata (stiffness in bone & joints)(Keshapatana (hair falling))

研究者

发起方
Government Ayurved Hospital Vadodara
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shraddhaben Hathishangbhai Jadav

Government Ayurveda Collage, Vadodara

研究点 (1)

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