AN OPEN LABELLED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VAAIVIDANGA CHOORANAM (INTERNAL MEDICINE) AND VAAIVIDANGA CHOORANAM (INTERNAL MEDICINE) WITH SIDDHAR YOGA MURAIGAL IN THE MANAGEMENT OF VATHASTHAMBAM (SCIATICA)
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
- 主要终点
- Through this trial, the therapeutic effectiveness of the trial drug and Siddhar Yoga Maruthuva Muruaigal towards the management of Vathasthambam (Sciatica) can be manifested.
研究概览
简要总结
It is an open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of,
A. INTERNAL MEDICATION
- Vaaividanga Chooranam
Dosage: 5 to 10 grams twice a day with Luke Warm Water, after food administered to Group A containing 20 participants for a period of 48 days
B. INTERNAL MEDICATION AND SIDDHAR YOGIC INTERVENTIONS
Synergistic effect of the INTERNAL MEDICATION Vaaividanga Chooranam along with SIDDHAR YOGIC INTERVENTIONS including Pranayamam, Salabhasanam, Sedhu Bandhasanam, Bhujangasanam, Tadasanam, Makarasanam and Savasanam to Group B containing 20 participants for a period of 48 days
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
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Herniated disc, Lumbar intervertebral disc bulge, Lumbar or Pelvic muscular spasm, Patient willing to sign Informed consent document, Patient who are willing for admission and stay in IPD or willing to attend OPD.
排除标准
- •Spondylolisthesis, Conus medullaris syndrome, Cauda equina syndrome, Sacroiliitis, Congenital anomalies, Pregnant women and Lactating mothers, Patients with any other serious systemic diseases, Patients who face difficulties to practice Siddhar Yoga Muraigal.
结局指标
主要结局
Through this trial, the therapeutic effectiveness of the trial drug and Siddhar Yoga Maruthuva Muruaigal towards the management of Vathasthambam (Sciatica) can be manifested.
时间窗: 48 DAYS
次要结局
- Comparative Assessment of change from base line lower back pain with Rolandmorris disability index between Group I and Group II will be achieved. Preference of Yogic Management as line of treatment for Vathasthambam can be acknowledged.(48 DAYS)