A Prospective, Randomized, Open Label, Two arm, Comparative Clinical Study to Evaluate the effect of IMMUNODAATâ„¢ Botanical Ingredient, in Post Covid-19 recovery
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters)
研究概览
简要总结
It was a prospective, randomized, open label, two arm, comparative clinical study to evaluate the effect of IMMUNODAATâ„¢ Botanical Ingredient, in Post Covid-19 recovery. The study was conducted at two sites in India. As per computer generated randomization list, subjects were randomized to one of the two study groups in 1:1 ratio. Subjects from Group I were asked to take IMMUNODAATâ„¢ Botanical Ingredient in a dose of 1 capsule twice daily (250 mg capsule) orally for 30 days + Conventional management (Standard of Care) as prescribed / advised by concerned health authorities for 30 days and subjects from Group II were asked to take conventional management (Standard of Care) as prescribed / advised by health authorities for 30 days. The primary objectives of the study were to assess comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters) and comparative assessment on blood related parameters like hematology, ESR and CRP. The secondary objectives of the study were to assess changes in post-clinical recovery i.e. stress, anxiety, appetite, digestion, sleep, bowel movements physical energy and stamina, change in health status assessment on WHO-QOL BRIEF, global assessment of overall change as per the investigator and subjects, assessment of tolerability of study drugs by physician and subjects at the end of the study, changes in vitals, occurrence of AE/SAE and change in laboratory safety parameters on day -3, day 0, day 15 and day 30.
Results and Conclusion:
The present randomized, comparative clinical study concludes that
Immunodaatâ„¢ played a significant role in reducing the symptoms of
mild Post COVID-19 or long COVID-19. In this study, use of
Immunodaatâ„¢ over 30 days helped to normalize the physical and
mental symptoms that occurred due to long COVID-19. In addition,
quality of life improved with the use of Immunodaatâ„¢. These potential
effects can be attributed to the active phyto-constituents having
potential anti-oxidant, nutritive, nervine tonic and adaptogenic effects
of Immunodaatâ„¢. Immunodaatâ„¢ was found to be safe for
consumption. Further studies with larger sample size involving blood
markers can validate the results of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who had mild to moderate symptoms [as per US-CDC classification) of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html) (Mild symptoms up to mild pneumonia) and is recovered clinically.
- •2.Patients will be recruited from the day of clinical recovery till next 15 days and having Post Covid Symptoms as per https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects 3.Ready to provide written informed consent for participation in the study 4.Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt.
- •/ local health authority throughout the study period.
排除标准
- •1.Subjects who had severe COVID-19 (moderate to severe pneumonia) 2.Subjects with post COVID 19 complications (those who had gone into severe type of COVID-19) 3.Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study 4.Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment.
- •5.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening 6.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
- •7.Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study 8.Allergies, known to be allergic to IMMUNODAATâ„¢ Botanical Ingredient 9.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.
结局指标
主要结局
1. Comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters)
时间窗: Day -3, Day 0, Day 15, Day 30
2. Comparative assessment on blood related parameters like hematology, ESR and CRP from baseline to 30 days.
时间窗: Day -3, Day 0, Day 15, Day 30
次要结局
- 1.Changes in post-clinical recovery i.e. stress, anxiety, appetite, digestion, sleep, bowel movements physical energy and stamina(2.Change in health status assessment on WHO-QOL BRIEF)