Randomised placebo controlled double blind clinical trial on the efficacy of AYUSHMANAS in the management of Smriti dourbalya (Cognitive deficit)â€
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the clinical efficacy of AYUSHMANAS in the Management of Smriti Daurbalya.
研究概览
简要总结
The current research study is aimed to assess the efficacy and safety of a coded Ayurvedic drug AYUSHMANAS. The ingredients of the trial drug have been proven to be safe in toxicity studies conducted in India and abroad.
Need and significance of the study: As there is no effective therapy in conventional system many patients seek alternative methods of treatment for Smritidourbalya. Thus there is a definite need to scientifically assess some of alternative treatment modalities.
In light of above, the present study has been proposed to evaluate the role of AYUSHMANAS in SmritiDaurbalya (Cognitive deficit).
Objectives:
PrimaryObjectives:
To assess the clinical efficacy of AYUSHMANAS in the Management of SmritiDaurbalya (CD).
SecondaryObjectives:
To assess the clinical safety of AYUSHMANAS in the children suffering from SmritiDaurbalya (CD).
Brief research plan:
The clinical study will be conducted in two groups. The cases will be assigned randomly in to two groups. The intervention will be as follows.
Group I:
1. AYUSHMANAS(Coded drug)
Dose : 250mg x 2 tab b i d
Form of Administration : Tablet
Route of Administration : Oral
Time of Administration : Twice a day after food.
Packing form : 120 tab / Pet jar
Anupana : Water
Duration of therapy : 6 months (180 days)
Group II:
Placebo tablet:
Dose : 250mg x 2 tab b i d
Form of Administration : Tablet
Route of Administration : Oral
Time of Administration : Twice a day after food.
Packing form : 120 tab / Pet jar
Anupana : Water
Duration of therapy : 6 months (150 days)
Sample size: Total 150.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Children of either sex aged in between 8 to 13 years.
- •Children with Intelligence Quotient 63 – 80 as per BKT
- •Willing and able to participate for 6 months (Consent to be obtained from Parent(s) / Guardian(s)/ Assent from children wherever possible).
排除标准
- •1.Children with a history of peptic ulcer disease, any gastric or duodenal surgery, gastrointestinal (GI) bleeding or other GI disorders.
- •2.Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac or hematological disorders.
- •3.Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2 > mg/dl, SGOT, SGPT >3times upper limit of normal; serum Bilirubin or Alkaline phosphatase >1.5 times upper limit of normal 4.Patient’s guardian who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
- •5.The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4 weeks prior to study entry.
- •6.The Children with a history of recent and clinically significant drug abuse.
- •7.The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc.
- •8.The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study.
- •9.Children in whom another investigational drug was used with in 3 months prior to entry in this study.
- •10.Children with poorly controlled epilepsy (H/o attack in last 3 months).
- •11.Children to whom BKT can’t be administered for any reason.
结局指标
主要结局
To assess the clinical efficacy of AYUSHMANAS in the Management of Smriti Daurbalya.
时间窗: The outcome shall be assessed periodically every 30 days once till the completion of 6 months intervention period.
次要结局
- To assess the clinical safety of AYUSHMANAS in the children suffering from Smriti Daurbalya.(duration of study 3 years)