a clinical trail on rhinitis in children with balachaturbhdra vati and chaturbhadrika vati two ayurvedic herbal compound
- Conditions
- Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, pratishyaya(rhinitis) ,
- Registration Number
- CTRI/2015/07/006055
- Lead Sponsor
- Institute for Post Graduate Teaching and Research in Ayurveda
- Brief Summary
The present study was planned as a simple randomized open ended clinical trial having two groups with aim to study the efficacy of *Balachaturbhadra Vati* (tablet) and *Chaturbhadraka Vati* (tablet)on *Pratishyaya* in pediatric age group. Both drugs in tablets form divided in group A *B**alachaturbhadra Vati* andin group B *Chaturbhadraka Vati* were given with dose fixation according to Young’s rule. Duration of intervention for both drugs in form of tablets was given after food twice a day with honey for duration of four weeks and followup period was another four weeks. A special scoring pattern was devised to assess the overall effect of therapy incorporating both subjective and objective parameters. The effect of treatment was tested for statistical significance by using appropriate statistical tests with use of software – Sigmastat for windows version 3.11.The effect of treatment of each formulation on clinical features and hematological parameters including biomarkers was tested for statistical significance with the help of Wilcoxon Signed Rank Test between the scores obtained before and after treatment within a group. The effectiveness between two formulations was compared by using Mann-Whitney Rank Sum Test between the results of two groups under trial. P value <0.05 was considered as statistically significant, P < 0.001 were considered as highly significant from the statistical evaluation.
The drug *B**alachaturbhadra Vati* showed statistically highly significant relief (P < 0.001) in Nasal Discharge with 91.49%, Nasal Congestion with 93.62%, fever with 97.78%, Duration of Bouts of cough with 97.67%, Frequency of Bouts of cough with 97.67%. 100% results on all three symptoms - Nature of Sputum, Crepitation and Rhonchi were found. On Rhonchi, significant result (P < 0.05) was observed while on Nature of Sputum and Crepitation, highly significant results (P < 0.001) were found. The drug showed an increase of 0.44% in Hb%, decrease of 1.03% in total W.B.C., increase of 28.96% in the ESR and decrease of 7.80 % in AEC. On all hematological parameters, insignificant changes (P > 0.05) were observed. In overall effect result was statistically highly significant (P < 0.001) with 66.45% relief and considering absence of recurrence in 93.62% patients during follow-up period overall effect was 75.17%.
The drug *Chaturbhadraka Vati* showed statistically highly significant relief (P < 0.001) in Nasal Discharge with 92.22%, Nasal Congestion with 93.33%, Duration- Bouts of cough with 93.02%, Frequency - Bouts of cough with 93.02%. 100% results on all four symptoms – Fever, Nature of Sputum, Crepitation and Rhonchi were found. On Rhonchi, insignificant result (P > 0.05) was observed while on Fever, Nature of Sputum and Crepitation, highly significant results (P < 0.05) were found. The drug showed an increase of 0.5% in Hb%, decrease of 0.94% and 42.10% in ESR and AEC respectively, increase of 10.78% in the Total WBC and 30.04% in Eosinophil. On all hematological parameters, insignificant changes (P > 0.05) were observed. In overall effect, the result was statistically highly significant (P < 0.001) with 65.15% relief and considering absence of recurrence in 93.33% patients during follow-up period overall effect was 73.81%.
During comparison of both drugs results on Hb% parameter both drugs showed almost equal improvement while on Total W.B.C. *Balachaturbhadra Vati* showed better improvement. On Eosinophils, AEC and ESR - *Chaturbhadraka Vati* observed better-effective compare to *Balachaturbhadra Vati*. On all hematological parameters, insignificant changes (P > 0.05) were observed during comparison. Duration and frequency of the cough *Balachaturbhadra Vati* showed a better improvement while on the symptoms Fever *Chaturbhadraka Vati* showed better improvement. Nature of Sputum, Crepitation, Rhonchi, Nasal Discharge and Nasal Congestion both drugs showed similar improvement. Insignificant changes (P > 0.05) were observed during comparison of both drugs.
*Balachaturbhadra Vati* provided an overall improvement of 75.17 % whereas *Chaturbhadraka Vati* showed an improvement of 73.18 %. The differences in overall effects of both the groups were statistically not significant (P > 0.05). No Adverse Drug Reaction was found during the trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- Children of both sex belonging to age group 2 to 12 years.
- Patient presenting with the classical symptoms of Pratishyaya like Nasa Srava, Peenasa, Kshavathu, Kasa, Shirogaurava etc.
- Patient presenting with recurrence of 1 episode in a month or 6 episodes in a year.
- Age below 2 years and above 12 years.
- Patients with congenital and anatomical deformities like DNS, nasal polyp etc.
- Patient presenting with symptoms of LRTI like Bronchial asthma, Pneumonia, Emphysema etc.
- Patient associated with systemic illness such as TB, HIV, and other chronic debilitating diseases and immune-compromised children.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nasatah strava(running nose) 14 days kasa(coughing) 14 days jvara(fever) 14 days
- Secondary Outcome Measures
Name Time Method nasatah strava(running nose) kasa(coughing)
Trial Locations
- Locations (1)
OPD Department Of Kaumarbhritya
🇮🇳Jamnagar, GUJARAT, India
OPD Department Of Kaumarbhritya🇮🇳Jamnagar, GUJARAT, IndiaDr Suhas A ChaudharyPrincipal investigator09427073351vdsuhaschaudhary@gmail.com