CTRI/2023/10/058253尚未招募3 期
A Clinical Study To Evaluate The Effect Of Soubhagya Shunthi Leha In The Management Of Sutika Makkala (Puerperal pain)
Dr Reeta C Vajramatti1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10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
- Effect of trial drug on the symptoms Udara Shoola, Adhmana, Shirashoola, Bastishools of Sutika Makkala(Puerperal pain).
研究概览
简要总结
- Sutika Makkala is one among 74 Sutika vyadi’s. Sutika Makkala occurs due to aggravation of vata Dosha and incomplete evacuation of Shonita from the Garbhashaya after Prasava that cause Shoola in Basti, Shiras and Udara.
- Sutika Makkala can be co- related to "Puerperal pain" characterized infrequent spasmodic pain in lower abdomen due to hypertonic contraction of the uterus to expel remainants of blood clots or any bits.
- Soubhagya shunti leha mentioned Bhaishajya Ratnavali is selected for this study to evaluate its effect in the management of Sutika Makkala(Puerperal pain).
- This is a single arm open label clinical trial. Total 30 patient of Sutika Makkala who fulfill the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Sutika Makkala are selected.
- Total Study duration will be 30 days and contain 3 visits (0th day, 15th day, 30th day), which includes administration of trial drug for 15 days and post medication follow up 30th days.
- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Married patients both primi Para and multi Para are taken.
- •2.Patients with full term normal vaginal delivery.
- •3.Patients willing to sign the consent form.
排除标准
- •1.Patients with Complication of IUD, Sepsis, PIH, and third stage of labour.
- •2.Patients with Systematic Disorders like Diabetes Mellitus, Hypertension, and Tuberculosis.
- •3.Instrumental Delivery, LSCS patients.
- •4.K|C|O –STDs, HIV, HBsAG.
结局指标
主要结局
Effect of trial drug on the symptoms Udara Shoola, Adhmana, Shirashoola, Bastishools of Sutika Makkala(Puerperal pain).
时间窗: 15th day , 30th day
次要结局
- Safety of trial drug and Adverse Drug Reaction(Aggravation of Symptoms of Sutika Makkala(Puerperal pain))
研究者
研究点 (1)
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