Evidence map›Paper›PMID 33728385›Full record

ArticleContemporary clinical trials communications2021

A randomized and comparative study to assess safety and efficacy of supplemental treatment of a herbal formulation -

Jayesh Dutt, Bhavdeep Ganatra, Nilay Suthar, Mohammedebrahim Malek, Bhakti Shukla, Krupali Shukla, Karna Shukla, Shreya Pandit, Manish Rachchh, Rina Gokani and 1 more

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Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jayesh DuttSmt. NHL Municipal Medical College & SVPIMSR, Ellisbridge, Ahmedabad, 380006, Gujarat, India.
Bhavdeep GanatraGanatra Ayurveda & Panchkarma Clinic, 125, Advait Complex, Opp Soham Tower, B /s Sandesh Press, Vastrapur, Ahmedabad, 380054, Gujarat, India.
Nilay SutharLG Hospital, Ahmedabad, Gujarat, India.
Mohammedebrahim MalekSmt. NHL Municipal Medical College & SVPIMSR, Ellisbridge, Ahmedabad, 380006, Gujarat, India.
Bhakti ShuklaM/s Shukla Ashar Impex Pvt. Ltd., Rajkot, 360001, Gujarat, India.
Krupali ShuklaM/s Shukla Ashar Impex Pvt. Ltd., Rajkot, 360001, Gujarat, India.
Karna ShuklaM/s Shukla Ashar Impex Pvt. Ltd., Rajkot, 360001, Gujarat, India.
Shreya PanditPandit Dindayal Gov. Hospital, Rajkot, 360001, Gujarat, India.
Manish RachchhM/s Accuprec Research Labs Pvt Ltd., Ahmedabad, 382213, Gujarat, India.
Rina GokaniM/s Accuprec Research Labs Pvt Ltd., Ahmedabad, 382213, Gujarat, India.
Mona BhalaniM/s Accuprec Research Labs Pvt Ltd., Ahmedabad, 382213, Gujarat, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe purpose of this study was to examine the effect of herbal formulation - Aayudh Advance on viral load as well as recovery duration in mild symptomatic patients diagnosed with Corona Virus Disease 2019 (COVID-19). It also aimed to study the effect of Herbal formulation - Aayudh Advance in terms of clinical improvement of various sign and symptoms in mild symptomatic COVID-19 patients.

methodOnce the patient suffice the requirement of inclusion, exclusion criteria of the study than as per the method of 'Covariate Adaptive Randomization' technique, patient was assigned in either Aayudh Advance arm (Test arm) or Control Arm. Here standard of Care treatment was given to all patients of both the arms. Treatment was given for the period of 14 days or till patient turned COVID-19 negative, which ever was earlier. Clinical signs and symptoms viz. body temperature, SpO 2, Scoring of Cough & Scoring of Shortness of breath were recorded on all 5 Clinical visits along with biochemical testing like RT-PCR (with CT value of E gene and RDRP gene), serum ferritin, CRP and NLR observed on weekly Visit.

resultTotal 74 patients were enrolled in the present study. Out of which 60 patients (30 patients in each group) have completed study as per the protocol, whereas 14 patients have voluntarily withdrawn from the study due to getting early discharge from the hospital. All patients in Aayudh Advance treatment group recovered (100%) after 14 days. This observed recovery was 15.38% more as compared to Standard of Care treatment alone. Further, there was statistically significant reduction (p < 0.05) in viral load as indicated by significant increase in CT value of E-gene and RDRP gene. Further, no patients reported any Adverse Reaction as well as no drug to drug interaction was observed with supplemental treatment with Aayudh Advance.

conclusionThe Aayudh Advance was found safe as well as more effective in terms of reduction of viral load. % recovery was more in Treatment arm as compared to Control arm in mild symptomatic COVID-19 patients.

Indexed as

Aayudh advanceAdverse drug reactionCovariate adaptive randomizationCOVID-19Standard of care (SOC)

Identifiers

PMID33728385
PMCPMC7948525

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.