A Clinical Study to Evaluate the role of Herbal Immunomodulators(sriveda sattva Pvt Ltd)in Boosting the Immunity among Health Care Workers assigned to COVID-19 Wards.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Measurement of serum levels of Anti-oxidant biomarkers such as Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH) at baseline (Day 0) and Day 15
研究概览
简要总结
Ayurveda, one of the world known renowned forms of Indian traditional medicine, mentions several immunity enhancing herbs. Goal of Ayurveda has always been to enhance or restore health to the optimum in addition to cure the disease. Herbs are very powerful with ingredients that have unique properties which helps strengthen immune system and improve respiratory health.
The herbal immunomodulators (Sri Sri Tattva) immunity kit includes Shakthi drops, Amruth tablet, Turmeric Plus tablet and TulsiArka.
Health care workers receiving Herbal Immunomodulator immunity kit which includes,
a) Shakthi drops: 5 drops 3 times a day
b) **Amruth tablet:**1 tablet 2 times a day
c) **Turmeric Plus tablet:**1 tablet 2 times a day
d) **TulsiArka:**10 drops 3 times a day
Duration of treatment: 14 days.
Shakthi drops, a polyherbal formulation (Amla, Ashwagandha, Bhringaraj, Brahmi, Amruth, Shankapushpi, Shatavari, Yashtimadhu) possess immunomodulatory action, antioxidant property and helps to strengthen immunity.[1]
Amruth (Tinosporacordifolia) has immunomodulatory property, boosts immunity, acts as rejuvenating agent, eliminates toxins, destroys pathogens and combats various infections.[2]
In Turmeric Plus tablet (Curcumin+Piperine), Piperine (active component of Pepper) enhances absorption and bioavailabilty of curcumin by 2000 fold, thus creating Curcumin complex, whereas Curcumin (active component of Turmeric) is responsible for anti-inflammatory, anti-oxidant, antiseptic, anti-microbial properties. Curcumin-piperine combination significantly improves oxidative and inflammatory status.[3]
Tulsi Arka has potent antimicrobial and anti-oxidant properties. It has multiple therapeutic actions including anti-inflammatory, cardioprotective and immunomodulatory effects.[4]
Hence, the herbal modulators (Sri Sri Tattva) can be useful in combating the novel coronavirus through its anti-oxidant and immunomodulatory action.
Visit 1/ Day 0/ baseline assessment
Participant will be given a thorough explanation of the study and written informed consent will be obtained.
Participant will be enrolled as per inclusion/exclusion criteria.
Details of Participant’s demographic characteristics, medical histories, concomitant medications and detailed physical/clinical evaluation will be recorded.
Blood sample will be collected for investigations - Anti-oxidant biomarkers [Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH)] and immune markers (IFN-β and IFN- γ)
Medication will be issued along with instructions regarding its use to the participant
Visit-2/ Day 7/ Follow-up 1:
Oropharyngeal swab will be done for the participants on 7th day of exposure or sooner if they develop influenza like illness for RT PCR (as per ICMR protocol) [5]
Visit-3/ Day 15/ Follow-up 2:
Anti-oxidant biomarkers [Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH)] and immune markers (IFN-β and IFN- γ) levels will be measured
Medication compliance, any intercurrent illness or change in concomitant medication will be recorded.
All observed or spontaneously volunteered side-effects will be recorded.
The study termination form will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 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.Participants willing to give written informed consent.(Annexure 1) 2.Participants of either sex aged between 18 and 60 years.
- •3.Health care workers -Nurses.
排除标准
- •Participants who are not willing to give consent for the study.
- •Participants with comorbidities like Hypertension, Type 1 or 2 Diabetes mellitus,
- •Participants suffering from chronic conditions affecting any of the major organs such as, Liver, Kidney, heart and Lungs
- •Pregnant women/lactating mothers
- •Participants on immunosuppressants.
结局指标
主要结局
1.Measurement of serum levels of Anti-oxidant biomarkers such as Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH) at baseline (Day 0) and Day 15
时间窗: Day 0 and Day 15
2.Measurement of serum levels of Immune biomarkers such as IFN-β and
时间窗: Day 0 and Day 15
IFN- λ at baseline (Day 0) and Day 15
时间窗: Day 0 and Day 15
次要结局
- Secondary outcome measure:(1.Number and severity of side-effects if any.)