Impact of Ayuraksha Kit in Covid-19- Community Based Prophylactic Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30,800
- 试验地点
- 13
- 主要终点
- Comparison of proportion of participants developing COVID-19 like symptoms in both the groups during the study period. [Number of participants with fever, cough, or other respiratory/systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhoea)]
研究概览
简要总结
As on 4th January 2022,a total of 1892 cases of Omicron variant have been reported from 23 states (Top5 being Maharashtra, Delhi, Kerala, Rajasthan, Gujarat) of India.Insuch situation, various measures, other than vaccination, to affect the immunesystem of the people positively also gain utmost importance to prevent theexhaustion of the overwhelmed health care system.
Interim reports of the community based prophylacticstudies have revealed the safety and the prophylactic efficacy of the ayurvedicmedicines and their combinations. One such prophylactic measure is Ayu RakshaKit which is a combination of four formulations viz., Chyawanprash, Samshamani Vati,AnuTaila (for nasal instillation) and Ayush Kwath choorna (3 gm powdercomprising Tulasi (Basil)-4 part, Dalchini (Cinnamon)-2 part, Shunthi (DryGinger)-2 Kalimirch (Black pepper)-1 part). The components of this kitindivisually are also studied for their prophylactic efficacy and safetyagainst COVID-19. The dosage of the formulations in the kit can be as follows -Chyawanprash 6 gm OD; Ayush kwath 75 ml OD; Samshamani Vati 500mg BD andAnutaila one drop in each nostril BD for at least one month.
Herbal ingredients of Ayush Kwath such as Tulsi,Marich, Sunthi and Dalchini are commonly used and easily available drugs inhome. On the basis of the experimental studies conducted on these ingredients,Ayush Kwath may collectively show immune-modulatory, antiviral, anti-oxidant,anti-inflammatory, antiplatelet,anti-atherosclerotic, hepato-protective,reno-protective properties and seems to be effective inimmuno-regulation forcontrolling viral infections like COVID-19. Pre-Clinical efficacy (immune modulatory) and safety (Regulatory Toxicology)evaluation of AYUSH Kwath was conducted by the National Institute of Nutrition.The interim results of an in-silico study being conducted IIT, Varanasi revealthat Beta-Sitosterol, a component of AYUSH Kwath, was found to be potential inhibitorof Mpro and RdRP of SARS-CoV-2.
Inview of this, the combination of these Ayurvedic formulations in the form ofAyuRaksha Kit may be studied for its potential as a prophylactic measure toenhance the immunity and general well-being of the people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a)Participants not having COVID-19 like symptoms, of age between 18 – 70 years, of any sex from the identified scheduled Tribe predominant areas/villages across India b)Participants who are ready to provide informed consent.
排除标准
- •i.Participants presenting with COVID-19 like symptoms ii.Participants diagnosed as case of COVID-19 by positive RT-PCR test within one month prior to inclusion iii.History of uncontrolled Diabetes mellitus or uncontrolled Hypertension iv.Participants having any disease condition that would require immediate medical or surgical intervention v.Known case of immune compromised state like HIV vi.Known cases of COPD, Tuberculosis, Cancer, Hepatitis vii.Participants on steroids or any immunosuppressive therapy viii.Those who have participated in any other clinical trial within one month prior to screening ix.Participants having a history of allergy to any medicine that is part of Ayuraksha Kit x.Women who are Pregnant or are planning for pregnancy during the study period or those who are lactating mothers.
结局指标
主要结局
Comparison of proportion of participants developing COVID-19 like symptoms in both the groups during the study period. [Number of participants with fever, cough, or other respiratory/systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhoea)]
时间窗: Time frame: baseline and at 30th day
次要结局
- 4.Percentage of drug compliance(Time frame: 15th and at 30th day)
- 1.Comparison of the severity of Respiratory symptoms if developed in both the groups through Wisconsin Upper Respiratory Symptoms Survey (WURSS-24) questionnaire.
- 2.Comparison of the clinical outcome of the participants developing COVID-19 like symptoms in both the groups, during the study period as per WHO Clinical progression scale (10 point).
- 3.Any change in psychological distress as an impact of exposure to COVID-19 among participants of both the groups assessed by using Kessler Psychological Distress Scale (K10).(Time frame: Baseline and at 30th day)
- 5.Proportion of participants exhibiting Adverse Events of any grade at in both groups(Time frame: 15th day and at 30th day)
- 6.Occurrence of Treatment Emergent Adverse Events (TEAEs)(Time frame:15th day and at 30th day)