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CTRI Number  CTRI/2015/07/006055 [Registered on: 30/07/2015] Trial Registered Retrospectively
Last Modified On: 11/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   a clinical trail on rhinitis in children with balachaturbhdra vati and chaturbhadrika vati two ayurvedic herbal compound 
Scientific Title of Study   A CRITICAL STUDY ON VEDANA ADHYAYA OF KASHYAPA SAMHITA W.S.R. TO PRATISHYAYA AND ITS MANAGEMENT WITH BALACHATURBHADRA VATI AND CHATURBHADRAKA VATI IN CHILDREN 
Trial Acronym  none 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suhas A Chaudhary 
Designation  PhD Scholar 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  A 10 Sweni Flats Nava Vadaj Ahmedabad Ahmadabad GUJARAT
Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 India
Jamnagar
GUJARAT
380013
India 
Phone  9427073351  
Fax    
Email  vdsuhaschaudhary@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof K S Patel 
Designation  Professor & Head 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT India
Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Prof K S Patel 
Designation  Professor & Head 
Affiliation  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar GUJARAT India
Department of Kumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9427574566  
Fax    
Email  drkspatel2007@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008  
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Department of Kaumarbhritya Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Jamnagar GUJARAT 361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suhas A Chaudhary  OPD Department Of Kaumarbhritya  PG HOSPITAL IPGT and RA Gujarat Ayurved University Jamnagar Gujarat Jamnagar GUJARAT
Jamnagar
GUJARAT 
09427073351

vdsuhaschaudhary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Name of Committee Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, pratishyaya(rhinitis) ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  balachaturbhadra vati  Dose fixed according to Young’s rule: Adult dose (Child age / Child age + 12)after food twice a day with honey duration 4 weeks  
Comparator Agent  chaturbhadraka vati  Dose fixed according to Young’s rule: Adult dose (Child age / Child age + 12)after food twice a day with honey duration 4 weeks  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
nasatah strava(running nose)
kasa(coughing)
jvara(fever) 
14 days
 
 
Secondary Outcome  
Outcome  TimePoints 
nasatah strava(running nose)
kasa(coughing)
jvara(fever)
Deha bala
Agni bala
Satva bala 
28 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/05/2015 
Date of Study Completion (India) 26/09/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not publish yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 

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 Balachaturbhadra Vati and in 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 Balachaturbhadra 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.

 

 

 

 

 

 

 

           

 

 
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