An open labelled double arm non randomized phase II clinical trial,“To Compare the effectiveness of Varma Thadaval Murai(Kai Varma Ennai-II-External oil) with Piratharani Kasayam(Internal) in the Management of Kumbavatham(Adhesive Capsulitis)”
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Adhesive Capsulitis (Frozen shoulder) is a disabling condition characterized by pain, stiffness, and restriction of shoulder movements, resulting in limitation of daily activities. In Varma literature, this condition is correlated with Kumbavatham and is managed using external and internal therapeutic approaches. The present study is open-labelled, double-arm, non-randomized phase II clinical effectiveness of Varma Thadaval Murai performed with Kai Varma Ennai-II and the internal administration of Piratharani Kasayam in a dose of 90 ml in patients with adhesive capsulitis. Eligible participants will be allocated into two treatment groups and treated for a period of 21 days. Clinical outcomes will be assessed by Shoulder Pain and Disability Index (SPADI) score and shoulder joint range of motion measured using a goniometer at baseline and Day 21. Safety and tolerability of the interventions will also be assessed during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presence of Pain, stiffness and restricted movements in the shoulder joint.
- •2.Idiopathic cases of adhesive capsulitis.
- •4.History of Diabetes Mellitus.
- •5.Patients willing to participate and sign the informed consent form.
- •6.Patients willing to undergo treatment and attend regular follow-up.
排除标准
- •1.History of fracture or surgery of the affected shoulder joint.
- •2.Autoimmune or inflammatory joint disorders affecting the shoulder.
- •3.Cardiovascular disease.
- •4.Tuberculosis or other active systemic infections.
- •5.Congenital deformities of the shoulder.
- •6.Pregnant and lactating women.
- •7.Skin diseases or infection over the affected shoulder region.
研究者
Dr A MOHIDEEN FATHIMA
Government Siddha Medical College and Hospital