Clinical evaluation of modified Shoolharan yoga and Trilokya Vijaya Vati in Dysmenorrhea.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dose and Duration required to relieve mild to moderate pain in the Dysmenorrhea will be assessed on the basis of WaLIDD score.
研究概览
简要总结
**Type of Study :**Interventional
**Level of Study :**OPD Level(Single Blind Triple arm)
Duration of Treatment : 9 doses in the 72 hours from the onset of the pain during menstural phase.
Method of Treatment/Intervention
Selected Drugs:1. Tab. SHYBE (Extract of Shoolharan yoga potentiated with bhavana of Shoolprashaman Mahakashaya)2. Tab. Trilokya Vijaya Vati( GMP Certified)3. Tab.Meftal-spasTMForm of Medicine :TabletDose of Drug:1. Tab. SHYBE 500 mg TDS2. Tab. Trilokya Vijaya Vati 125 mg TDS3. Tab.Meftal-spasTM (Mefenamic acid 250 mg & Dicycloamine10 mg)TDS**Route of Administration:**Oral
Preparation And Storage of Medicine
The medicine will be prepared under strict aseptic procedure. Tablets from the extract of Shoolharan Yoga bhavitwith Shoolprashaman Mahakashaya(SHYBE) will be prepared. The tablets will be stored in air tight containers.
Procedure
The selected patients for trial will be randomly divided into following three groups (20 patients in each group)
| S. No. |
GROUPS
DRUG
DOSE(As Per classical)
|1
Group A
Tab. SHYBE
500 mg
|2
Group B
Tab. TVV
125 mg
|3
Group C
Tab. Meftalspas
200 mg
Assessment
- It will be done after 30 min, 1hr after drug intake on the basis of Visual Analogue Scale before treatment and after drug intake.
- Assesment of result of Therapy after 3 days on the basis of WALIDD Score.
Follow Up
The follow up will be done after 72 hr.
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
- 12.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female Patients married /unmarried of age group 12-45 year will be selected.
- •Pain should be cardinal features.
- •Patients with the complaint of Dysmenorrhea from at least two consecutive cycles which last upto few hours to few days.
- •4.Patients irrespective of the religion, occupation having fair general condition will be selected for the study.
排除标准
- •Dysmenorrhea which require emergency intervention such as faint, acute abdomen pain.
- •Menorrhagia, Metrorrhagia patients should be excluded.
- •3.Patients existing with disease of cardiovascular, renal or hematopoietic systems and mental diseases will be excluded.
结局指标
主要结局
Dose and Duration required to relieve mild to moderate pain in the Dysmenorrhea will be assessed on the basis of WaLIDD score.
时间窗: Outcome will be evaluated after 3 days of therapy.
次要结局
- Degree of improvement in frequency and duration of pain will be assessed(within 72 hours of administration of drug)
研究者
Dr Khem Chand Sharma
Rishikul Campus , Haridwar , Uttarakhand Ayurved University