DaburSubjective
- Cough
- Fever
- Running nose
- Loss of appetite
- Loss of weight
- Dyspnoea
- Chest pain
- Headache
- Fatigue
- Weakness
- Muscle and joint pain
- Sleep abnormalities
- Forgetfulness
- Irritability
- Difficulty concentrating
- Depression and other complaints
Clinical Study 2 · Double-blind · Placebo-controlled
Effect of DCP on Seasonal Influences and General Health
Designed to evaluate beneficial or adverse effects of DCP used throughout the year, and clinical efficacy in subjects with non-specific ailments associated with seasonal influences in the absence of underlying organic disease.
Symptom relief · Summer and rainy combined
75.88%
DCP relief, against 25% placebo relief
Design
Double-blind
Placebo-controlled; conducted over two years across Summer, Rainy and Winter seasons, plus a round-the-year cohort
Population
15 to 75 years
Men and women without chronic organic disease but with non-specific ailments
Intervention
12 g twice daily
CP-A: Dabur Chyawanprash. CP-B: Placebo. Identical coded containers blinded investigator and user.
Duration
3 to 12 months
Seasonal cohorts three months; round-the-year cohort twelve months
Study objective
The seasonal-influence study was designed to evaluate:
- Beneficial and/or adverse effects of DCP when used throughout the year; and
- Clinical efficacy in subjects experiencing non-specific ailments associated with seasonal influences in the absence of underlying organic disease.
Study design and population
The study was a double-blind, placebo-controlled clinical study. Participants were men and women aged 15–75 years without chronic organic disease but presenting with non-specific complaints such as loss of appetite, fatigue, weakness, malaise, recurrent cold/allergy, running nose, fever, sleep abnormalities, muscle and joint pain and perspiration.
Subjects with chronic respiratory disease, tuberculosis, lung cancer, chronic indigestion or gastric ulcer, diabetes, renal impairment, serious cardiovascular disease, liver disease and pregnancy were excluded.
The study extended over two years and included summer, rainy and winter seasons, together with a separate round-the-year group. Seasonal cohorts received three months of therapy, whereas the round-the-year group received treatment for one year.
The administered dose was 12 g twice daily. The products were placed in similar containers with coded labels to blind the investigator and user.
Outcome measures
Objective
- Haemoglobin
- Total and differential leukocyte counts
- ESR
- FEV1
- FEV1/FVC
- Plasma cortisol
- IgE
- C3 and C4
Clinical symptom results
Summer and rainy combinedDCP · CP-A
129 of 170
symptoms relieved, 75.88%
Placebo · CP-B
35 of 140
symptoms relieved, 25%
For the summer and rainy-season cohorts combined, the reports 170 symptoms in the DCP group, of which 129 were relieved, compared with 35 relieved out of 140 symptoms in the placebo group. The reported percentage relief was 75.88% with DCP versus 25% with placebo.
The symptoms includes cough, dyspnoea, running nose, feeling of being run down, weakness, loss of appetite, fatigue, muscle pain, joint pain and perspiration.
Immunological findings
Serum IgE · % change from baseline| Cohort | DCP group | Placebo |
|---|---|---|
| Summer | ≈ 15% decrease | Small reduction |
| Rainy season | ≈ 30% decrease | Increase reported |
| Winter | ≈ 11.6% decrease | Small reduction |
| Round-the-year | ≈ 23% decrease | Small reduction |
The seasonal study reported reductions in serum IgE with DCP. The placebo group showed smaller reductions or, in the rainy-season cohort, an increase in IgE.
Changes in C3 and C4 were described as variable, and the reported changes were not significant in the seasonal comparisons and that the variability warranted larger studies.
Haematological and respiratory findings
ESR · reduction with DCPApproximate % reduction in ESR in the DCP cohorts of the seasonal-influence study. The placebo group showed an increase in ESR.
DCP was associated with reductions in ESR across the reported seasons.
Improvements in pulmonary function were also reported. FEV1 increased by approximately 11.8% in the summer DCP group and approximately 11.83% during winter, with an increase in the FEV1/FVC ratio also reported during summer. A gradual improvement in the two PFT parameters was reported in the round-the-year DCP group.
Plasma cortisol
ReductionThe study evaluated plasma cortisol as a marker of stress. The reported reductions after three months of DCP treatment were approximately 22.15% during summer, 12.9% during the rainy season and 22.12% during winter.
In the round-the-year group, a reduction of approximately 25% was reported at the end of treatment, described in the source as statistically significant (P < 0.01).
Biochemical safety observations
Liver
No significant adverse effect
Renal
No significant adverse effect
Glucose
Remained within safe range
Lipids
No adverse influence
The data reports no significant adverse effect of DCP on liver or renal function. Blood glucose remained within the reported safe range and no adverse influence on lipid profile was observed.
Key takeaway
Overall, DCP was well tolerated with no safety concerns reported.
- Significant relief of non-specific symptoms, 75.88% against 25% with placebo.
- Reductions in serum IgE across all seasons.
- Reductions in ESR and plasma cortisol.
- Improvements in pulmonary function, FEV₁ and FEV₁/FVC.
- No significant adverse effects on key biochemical safety parameters.