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临床试验/CTRI/2018/02/012189
CTRI/2018/02/012189已完成1 期

An open clinical trial for the assessment of efficacy of Pankajakasthuri Orthoherb Tablet in patients with osteoarthritis.

PANKAJAKASTHURI AYURVEDA MEDICAL COLEGE AND POST GRADUATE CENTER1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年5月25日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
More than 80% of participants had 100% relief

研究概览

简要总结

Osteoarthritis is a joint disease that mostly affects cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint.

This study is a open clinical trial to assess the efficacy of PANKAJAKASTHURI ORTHOHERB TABLET in 500 patients with Osteoarthritis who visited the OPD of PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE HOSPITAL from 25-05-2016 to 16-12-2016. The severity of disease was graded under four scoring scales. The observation and calculations were made on the basis of relevant statistical methods. The primary outcome measure was done at the end of 6th month and secondary outcome was measured at the end of 2nd month and 4th month. The observations on the basis of followup were also taken for statistical analysis. The statistical analysis by using paired t test produced the success rate by attaining P<0.001 shows the medicinal value of the product is highly significant in treating the disease- Osteoarthritis with high percentage of improvement.

There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan. There exist remedial measures to treat pain associate with skeletal system in ancient Ayurvedic texts where elaborate descriptions are available. Mainly Vatavyadhi affecting sandhi s were given importance. The form or kalpana differs in accordance with the different conditions of disease pathogenesis. Even though very effective kashayakalpanas are available, the palatability and preservation make its less acceptance among patients. Thus, an effective medicine in the form of ORTHOHERB tablet is tried among the outpatients of Pankajakasthuri Ayurveda Medical College OPD and found effective in treating pain associated with joint disorders by reverting actual sampraptighatakas of the disease process.

EFFECT OF TREATMENT ON SIGNS AND SYMPTOMS

1. EFFECT ON PAIN

The mean score of the symptoms which was 3.410 before treatment reduced to 2.436 with the mean difference of 0.974 ± 0.574 on the 2nd month after the treatment, which further reduced to 1.102 (mean difference of 3.308 ± 0.605) during 6th month follow up.

The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001.

2. EFFECT ON OEDEMA

The mean score of the symptoms which was 2.460 before treatment reduced to 1.562 with the mean difference of 0.898 ± 0.303 on the 2ND month after the treatment, which further reduced to 0.000 (mean difference of 2.460 ± 0.711) during 6th month follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001.

3. EFFECT ON STIFFNESS

The mean score of the symptoms which was 3.208 before treatment reduced to 2.208 with the mean difference of 1.000 ± 0.506 on the 2ND month after the treatment, which further reduced to 0.102 (mean difference of 3.106 ± 0.746) during 6th month follow up. The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001.

4. EFFECT ON TENDERNESS

The mean score of the symptoms which was 2.616 before treatment reduced to 1.490 with the mean difference of 1.126 ± 0.565 on the 2nd month after the treatment, which further reduced to 0.000 (mean difference of 2.616 ± 0.487) during 6thmonth follow up.

The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001.

5. EFFECT ON PAIN ON MOVEMENT

The mean score of the symptoms which was 3.336 before treatment reduced to 2.360 with the mean difference of 0.976 ± 0.482 on the 2nd month after the treatment, which further reduced to 0.102 (mean difference of 3.234 ± 0.767) during 6th month follow up.

The change that occurred with the treatment is greater than would be expected by chance; there is a statistically high significant change at p<0.001.

From the study it is clearly evident that the trail drug is high significant in managing osteoarthritis and here by declaring that the study was completed and closed.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Classical Signs and Symptoms of Osteoarthritis.
  • Pain during movement and weight bearing, Swelling, Stiffness. Also fulfilling the classical criteria of Sandhigatavata mentioned in Ayurvedic texts- Shoola i.e. Akunchana prasarana vedana, Shotha and Sthambha.

排除标准

  • Secondary Arthritic conditons, Fractures, Ligament tear, Dislocation, Osteomyelitis, SLE, Tumors Bone density disorders, Anatomical joint deformities, NSAID/Analgesic/steroid treatment for Osteoarthritis, Patients who have undergone major surgery in the affected joint.

结局指标

主要结局

More than 80% of participants had 100% relief

时间窗: SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

STIFFNESS

时间窗: SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

Assessment criteria was based on the grading of following parameters

时间窗: SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

PAIN

时间窗: SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

TENDERNESS

时间窗: SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

SWELLING.

时间窗: SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS

次要结局

  • More than 50% of participants got relief of symptoms ranging from MILD to MODERATE.(Assessment criteria was based on the grading of following parameters)
  • An average of 60% of participants got MODERATE to CONSIDERABLE relief of symptoms.(Assessment criteria was based on the grading of following parameters)

研究者

发起方
PANKAJAKASTHURI AYURVEDA MEDICAL COLEGE AND POST GRADUATE CENTER
申办方类型
Other [AYURVEDA MEDICAL COLLEGE AND POST GRADUATE CENTRE IN PRIVATE SECTOR]

研究点 (1)

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