跳至主要内容
临床试验/CTRI/2025/02/081199
CTRI/2025/02/081199尚未招募3 期

A Randomised Open Labelled Comparative Clinical STudy to Evaluate the Efficacy of Janu Basti with Mahanarayana Taila in Comparison to Ultrasound Therapy in the Management of Janu Sandhigata Vata vis-a-vis Osteoarthritis of Knee Joint.

Divyani P Das1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
•To evaluate the efficacy of Janu Basti with Mahanarayana Taila in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.

研究概览

简要总结

•      Sandhigatavata is compared with osteoarthritis in contemporary medical science due to the similarities in their symptoms. Janu Sandhigatavata is characterized by symptoms such as pain, stiffness, swelling, crepitus, and reduced range of motion in the knee joint. These symptoms are believed to arise due to an imbalance of Vata Dosha, leading to the accumulation of Ama  and the deterioration of cartilage and synovial fluid in the knee joint The procedures like, Snehana, Swedana, Lepa, Upanaha, Agnikarma are indicated in the cure of Sandhigatavata .Swedana is one of the important Upakrama mentioned for Vata Dosha. As Pradhana Karma, Swedana can be adopted according to the disease condition.

•      Ultrasound therapy is used as a complementary treatment in physical therapy regimens focused on managing pain and aiding in the healing of soft tissue injuries. The treatment exerts therapeutic effects through thermal (continuous UST) and non-thermal (pulsed UST) modalities. Continuous UST achieves the thermal effect and is purposed to produce analgesia through temperature elevation, which increases capillary permeability and tissue metabolism, thereby enhancing fibrous tissue extensibility and pain thresholds. Non-thermal effects are achieved by modulating cell membrane permeability, increasing protein synthesis, and activating immune response near the injury site, which may stimulate regeneration of damaged tissue.  Hence for an effective solution, an attempt is made to evaluate and compare Janu Basti with Mahanarayana Taila and ultrasound therapy in the management of Janu Sandhigatavata.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects between the age group of 21 to 60 years irrespective of gender, religion, occupation, and socioeconomic status.
  • Subjects presenting with Pratyatma Lakshanas of Janu Sandhigatavata.
  • Subjects fit for Janu Basti and Ultrasound therapy.
  • Subjects who are willing to give a written consent for the treatment.
  • Obesity and diabetes mellitus patients under medications can be included in the study, provided it is controlled.

排除标准

  • Subjects below 21 years and above 60 years of age.
  • Subjects unfit for Janu Basti and Ultrasound therapy, including those with skin lesions, cuts, wounds, rashes, or skin diseases.
  • Conditions associated with fractures and other systemic illnesses that interfere with the treatment protocol.
  • Subjects with skin diseases and open lesions on knee joints.
  • Subjects with an established diagnosis of Gouty arthritis and Rheumatoid arthritis.
  • Pregnant and lactating women.

结局指标

主要结局

•To evaluate the efficacy of Janu Basti with Mahanarayana Taila in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.

时间窗: 1st day: Before commencement of treatment. | 8th day: After completion of the treatment. | 15th day: 7 days after completion of the treatment.

•To evaluate the efficacy of ultrasound therapy in Janu Sandhigatavata on the basis of changes noted in total score in important subjective parameters in the institute’s clinical set up.

时间窗: 1st day: Before commencement of treatment. | 8th day: After completion of the treatment. | 15th day: 7 days after completion of the treatment.

•To compare the efficacy of Janu Basti with Mahanarayana Taila and ultrasound therapy in Janu Sandhigatavata.

时间窗: 1st day: Before commencement of treatment. | 8th day: After completion of the treatment. | 15th day: 7 days after completion of the treatment.

次要结局

未报告次要终点

研究者

发起方
Divyani P Das
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrDivyani P Das

Sri Sri College of Ayurvedic Science and Research

研究点 (1)

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