A Pilot Study To Evaluate The Effectiveness Of Sarapanga Vilvathy Legiyam In The Treatment Of Acid Peptic Disease (Erigunmam)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary outcome assessed by comparing the reduction of clinical symptoms before & after treatment by using Gastro-intestinal symptoms rating scale (GSRS).
研究概览
简要总结
AcidPeptic Diseases (APD) includes GERD, Peptic ulcer diseases(PUD). APD is thecommon condition reported in daily practice and which is due to the hyperacidity or reduced mucosal protection. Globally,the number of prevalent cases of GERD increased by 77.53% from 441.57 million(95% UI 383.48– 496.84) in 1990 to 783.95million (689.55–876.53) in 2019 and in worldwide PUD affects four millionpeople annually.Clinical presentation of patients withGERD and PUD are Heart burn with regurgitation or without regurgitation,epigastric abdominal pain,abdominal bloating, nausea, vomiting, Sleepdisturbances, Pain awakening at night, weight loss, GI bleeding, anemia, melena.
In Siddha, Accordingto "Yugi vaithya sinthamani", Gunmam is classified into eight types. Inwhich Eri Gunmam is one among them. The signs and symptoms of this disease arecorrelated with Acid Peptic disorder in modern science.
Inthe Siddha vaidhya thirattu text book, Sarapanga vilvathy legiyam is speciallyindicated for Envagai gunmam (Acid peptic disease), Vellokkalam (Nausea),Vaikasappu (Bitter taste in tongue), Vaineerooral (Increased salivation),Vayiru mantham (Indigestion). These are all very much related to Acid pepticdisease.
Sarapangavilvathy legiyam is a herbalmedicine having 38 ingredients. Out of which, 16 main drugs are roots which haveproven activities of anti ulcer,anti-secretory and cytoprotective. i.e.vilvaver kattai (root of Aeglemarmelos.L) have proven anti-ulcer activity(5). Mutkavelai ver(Root of Tephrosia purpurea.L) have proven anti-ulcer activity(6)Saaranaiver (root of Trianthem adecandra.L) have proven antiulcer, anti-secretoryand cytoprotective effects(7) Sangam ver (root of Azema tetracantha.L) have proven Anti-ulceractivity(8).
Sothe aim of this treatment with sarapanga vilvathy legiyam includes relief ofsymptoms, enhancement of ulcer healing in the affected mucosa and prevention ofrecurrence.This formulation has not undergone any clinical trial for thiscondition so far.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with the symptoms of epigastric abdominal pain, Heart burn with or without regurgitation, abdominal bloating, nausea, vomiting, belching, hematemesis (Any 3 or 4) 2.Willing to take endoscopy before and after the trial period.
- •3.Willing to give blood specimen for the investigation when required.
- •4.Patient who are willing to sign informed consent form.
排除标准
- •1.k/c/o Diabetes mellitus 2.k/c/o Hypertension 3.k/c/o Cardiac ailments 4.Known Cases of Acute Abdomen (Appendicitis, Pancreatitis, Cholecystitis) 5.k/c/o Hiatus hernia 6.k/c/o Gastric/ Esophageal Carcinoma 7.k/c/o Liver cirrhosis 8.Pregnancy and lactation.
结局指标
主要结局
Primary outcome assessed by comparing the reduction of clinical symptoms before & after treatment by using Gastro-intestinal symptoms rating scale (GSRS).
时间窗: 6 months
次要结局
- Secondary outcome is assessed by comparing the Endoscopic results before & after treatment for 20 percentage of selected patients.(6 months)