DaburChyawanprash
Chyawanprash DecodedPreclinical and Clinical Science
Legacy of scienceIn this section
The safety and tolerability profile of Dabur Chyawanprash has been evaluated through a combination of nonclinical toxicological studies and human clinical investigations conducted across different populations and durations of exposure. The available evidence includes acute and repeated-dose oral toxicity studies in rodents, as well as clinical studies in adults, children and healthy individuals.
Clinical safety assessments included adverse events (AE) and serious adverse event (SAE) monitoring, vital signs and, where reported, laboratory parameters including hepatic, renal, metabolic and lipid related parameters.
Overall, the available evidence indicates a favourable safety and tolerability profile at the doses and durations investigated. In the randomized pediatric clinical study, no AE or SAE was considered related to the study product. Physician assessment classified 92.45% of participants receiving DCP as having excellent overall safety, with the remaining participants classified as good or fair.
In the 90 day COVID-era comparative clinical study, 106 AE episodes were reported, comprising 52 in the DCP group and 54 in the control group. Two events in the DCP group were considered possibly related to product consumption: pruritus ani and mild skin allergy. Both were mild and resolved with symptomatic treatment. Six SAEs were reported overall, one in the DCP group and five in the control group; none was considered related to the study product.
The nonclinical safety studies further support these observations. Acute oral toxicity studies reported no treatment related toxicity at 2,000 mg/kg body weight, while 28-day and 90-day repeated dose studies reported a NOAEL of 1,000 mg/kg body weight/day.
>2,000
mg/kg body weight, rats and mice
1,000
mg/kg body weight/day, 28 and 90 days
92.45%
physician assessment
None
in the reported randomized studies
The available nonclinical and clinical evidence supports a favourable safety and tolerability profile for DCP when consumed at the investigated doses and for the durations evaluated. No treatment related serious safety signal has been identified in the clinical evidence available.
The nonclinical safety data includes acute oral toxicity, 28-day repeated dose oral toxicity and 90-day repeated dose oral toxicity studies, including recovery period observations.
The studies evaluated clinical signs, mortality, body weight, food consumption, hematological parameters, biochemical parameters, organ weights, gross pathology and histopathology, as applicable.
| # | Study | Species | Dose | Duration | Key findings |
|---|---|---|---|---|---|
| 1 | Acute oral toxicity | Wistar rats; Swiss albino mice | 2,000 mg/kg | Single dose + 14-day observation | No treatment related toxicity or mortality; LD50 >2,000 mg/kg |
| 2 | 28 day repeated dose | Wistar rats | 250, 500, 1,000 mg/kg/day | 28 days + recovery | No treatment related toxicity; NOAEL 1,000 mg/kg/day |
| 3 | 90 day repeated dose | Wistar rats | 250, 500, 1,000 mg/kg/day | 90 days + recovery | No treatment related toxicity; NOAEL 1,000 mg/kg/day |
Doses investigated in the nonclinical programme, drawn to scale.
A single oral dose of 2,000 mg/kg body weight of Dabur Chyawanprash was administered to Wistar rats and Swiss albino mice of both sexes. Animals were observed for 14 days for treatment-related clinical signs, body-weight changes and mortality.
No treatment-related signs of toxicity or body-weight loss were observed and all animals survived throughout the observation period. The reported LD50 was greater than 2,000 mg/kg body weight in both rats and mice.
DCP was administered orally once daily to Wistar rats at 250, 500 and 1,000 mg/kg body weight/day for 28 consecutive days, with a recovery group evaluated following cessation of treatment.
No treatment-related mortality or clinically significant treatment-related signs were reported. Body weight gain and food consumption were comparable with controls. No treatment-related abnormalities were identified in the reported haematology, clinical biochemistry, organ-weight, gross-pathology or histopathology assessments. The reported NOAEL was 1,000 mg/kg body weight/day.
A 90-day oral repeated-dose study was conducted in Wistar rats at 250, 500 and 1,000 mg/kg body weight/day, including a recovery group.
The study evaluated clinical observations, mortality, body weight, food consumption, haematology, clinical chemistry, urinalysis, organ weights, gross pathology and histopathology. No treatment-related mortality or treatment-related abnormalities were reported in these assessments. The reported NOAEL was 1,000 mg/kg body weight/day.
Nonclinical safety conclusionNo treatment related toxicological observation in the nonclinical toxicology studies with NOAEL of 1,000 mg/kg body weight/day in both 28 day and 90 day repeated dose studies.
Clinical safety data is available from studies conducted in adults with respiratory/allergy-related conditions, adults evaluated across seasonal conditions, healthy school-going children and healthy individuals evaluated during the COVID-19 pandemic.
The clinical evidence includes six months in the pediatric randomized study and 90 days in the COVID-era comparative study.
The pediatric randomized study enrolled 702 children, of whom 627 completed the 6 month study. None of the 75 discontinuations was attributed to an adverse event.
A total of 248 participants reported AEs: 133 in the Dabur Chyawanprash group and 115 in the control group. A total of 599 AE episodes were recorded, comprising 316 in the DCP group and 283 in the control group. The study report states that these AEs were not related to the study drug.
Fourteen SAEs were reported: six in the DCP group and eight in the control group. None of the SAEs was considered related to the study drug or study procedure.
Pulse, respiration and body temperature assessments did not identify a significant treatment-related safety finding.
Physician global safety assessment
| Safety classification | Participants | Percentage |
|---|---|---|
| Excellent | 289 | 92.45% |
| Good | 18 | 5.87% |
| Fair | 5 | 1.68% |
| Poor | 0 | 0% |
All participants in the Chyawanprash group were classified as having excellent, good or fair overall safety, with no participant classified as having poor safety.
In the six-month randomized pediatric study, Chyawanprash was well tolerated. No AE or SAE was considered related to the study product, no clinically meaningful safety signal was identified from vital-sign assessment, and physician assessment classified all participants as having excellent, good or fair overall safety.
The COVID-era study included 721 randomized participants, with 696 efficacy-evaluable/completer participants. The study was conducted at five Ayurveda institutions across three states and was registered with the Clinical Trials Registry of India (CTRI/2020/05/024981). Participants were followed for 90 days with clinical and telephonic assessments that included adverse-event monitoring.
A total of 106 AE episodes were reported: 52 in the Chyawanprash group and 54 in the control group. Two AEs were considered possibly related to Chyawanprash: pruritus ani and mild skin allergy. Both were classified as mild and resolved with symptomatic treatment.
6 SAEs occurred: 1 in the Dabur Chyawanprash group and 5 in the control group. None was considered related to the study product.
5 participants required hospitalization: 1 DCP participant for four days and 4 control participants for a total of 43 days. No participant in the DCP group required ICU admission or ventilator support, and no mortality occurred in that group.
Overall safety assessment
| Assessment | Participants | Percentage |
|---|---|---|
| Excellent | 223 | 63.53% |
| Good | 113 | 32.19% |
| Fair | 15 | 4.27% |
| Poor | 0 | 0% |
Participant self-assessment was similarly favourable, with 64.38% reporting excellent safety, 31.33% good safety, 4.27% fair safety and 0% poor safety.
Interpretive cautionThese hospitalization findings are study observations and should not be presented independently as proof of a protective effect against severe COVID-19.
The seasonal clinical study included assessment of parameters relevant to hepatic, renal and metabolic safety. The published report states that regular Chyawanprash consumption did not adversely affect reported liver-function parameters, renal-function parameters, blood glucose or lipid profile.
In the available seasonal clinical study, no clinically relevant adverse effects on reported hepatic, renal, glucose or lipid parameters were identified during the study period.
The clinical safety database for Dabur Chyawanprash demonstrates a favourable overall tolerability profile across the studied adult, pediatric and healthy populations. In the six-month randomized pediatric study, no AE or SAE was considered related to DCP. No product related toxicity was observed in the seasonal clinical trial. In the 90-day comparative study, the incidence of recorded AEs was similar between treatment groups, with only two mild events considered possibly related to DCP; both resolved with symptomatic treatment. No SAE in that study was considered related to the product.
Taken together with the acute and repeated-dose nonclinical toxicology studies along with clinical studies, the available results support a favorable safety and tolerability profile for Dabur Chyawanprash at the investigated doses and durations.
| Safety parameter | Evidence | Finding |
|---|---|---|
| Treatment-related AEs | Pediatric randomized study | None reported |
| Treatment-related SAEs | Pediatric randomized study | None reported |
| Treatment-related AEs | 90-day comparative study | Two mild events possibly related |
| Treatment-related SAEs | 90-day comparative study | None |
| Vital signs | Pediatric study | No significant safety finding |
| Hepatic parameters | Seasonal study | No adverse effect reported |
| Renal parameters | Seasonal study | No adverse effect reported |
| Blood glucose | Seasonal study | No adverse effect reported |
| Lipid profile | Seasonal study | No adverse effect reported |
| Physician global safety | Pediatric study | 92.45% excellent; remainder good/fair |
| Physician global safety | COVID-era study | 63.53% excellent; 32.19% good; 4.27% fair; 0% poor |
| Nonclinical NOAEL | 28-/90-day studies | 1,000 mg/kg/day |
| Claims | Evidence basis | Key observation |
|---|---|---|
| Favourable overall tolerability | Clinical + nonclinical evidence | Available clinical and nonclinical studies support a favourable overall tolerability profile at the investigated doses and durations. |
| No treatment-related SAE signal | Pediatric + COVID-era studies | No SAE was considered related to DCP in the reported randomized clinical studies. |
| Mild product-related events | COVID-era study | Two mild AEs were considered possibly related to DCP; both resolved with symptomatic treatment. |
| Pediatric six-month safety | Randomized pediatric study | In a six-month randomized pediatric study, no AE or SAE was considered related to the study product. |
| Nonclinical NOAEL | 28-/90-day studies | A NOAEL of 1,000 mg/kg/day was reported in the 28- and 90-day repeated-dose rodent studies. |
| Laboratory safety | Seasonal study | No clinically relevant adverse effect on reported hepatic, renal, glucose or lipid parameters was identified during the study period. |