The present study is “A Randomized open-labelled controlled clinical study
to evaluate the efficacy of Haritakyadi Kwatha in the management of Pittaja
Mutrakrichra with special reference to Lower Urinary Tract Infection.”
The dissertation Includes two parts. First Part of Dissertation deals with
Diseases Introduction, Review of literature which is composed of Historical
review, Shareera Rachana and Kriya Shaareera of mutravaha srotas, Nirukti,
Paribhasha, Paryaya, Nidana panchaka, , Sadhyasadhyata, Vyavachedaka nidana,
Chikitsa, Pathyapathya. It also includes Etymology & Definition of Urinary tract
infection, Anatomy - physiology of Lower urinary tract, Formation &
Characterstics of urine , Associated risk factors, Clinical features, Pathogenesis,
Diagnostic approach, Laboratory Investigations, Differential diagnosis and
Management of Lower Urinary Tract Infection. Part two includes Materials and
methods, Observations, Results, Discussion on observation, results and probable
mode of action of interventions, conclusion and summary.
The study was completed with 30 subjects were equally assigned into 2
groups - Trial group and Control group. The 15 subjects in each group were
selected using convenience sampling. The intervention in Trial group was
Haritakyadi Kwatha whereas the intervention in Control group was
VareeVidaryadi Kwatha.
Trial period was for 14 days followed by 7 days of drug free follow up
period. Interventions were statistically assessed on 0th day (Before treatment),14th
day(After Treatment) and 21st
day (drug free follow up).
• Assessment was done on the basis of subjective criteria with
appropriate grading:
1.Peeta mutrata (Yellowish discolouration of urine)
2.Sadaha mutrata ( Burning sensation while urinating )
3.Krichra mutrata / Saruja mutrata ( Pain /difficulty in urination)
4.Muhurmuhur pravrutti (Frequent urge of urination)
5.Sarakta mutrata (Blood mixed urine)
• Assessment was done on the basis of objective criteria with
appropriate grading:
1. Presence of Pus cells
2. Presence of Red Blood Cells
3. Positive urine culture (Presence of bacteria)
Statistical analysis for above parameters were done using Unpaired t test,
Repeated measures of ANOVA, Paired t Test, Mann Whitney U Test, Friedman
test, Wilcoxon Sign rank test.
From the above observations it was concluded that on assessing results, it
was observed that both Haritakyadi Kwatha and VareeVidaryadi Kwatha gave
positive outcome in objective and subjective parameters of Pittaja mutrakrichra.
Statistical analysis of the results within Trial group and Control group showed
statistically significant results in reducing the clinical features of LUTI.
On comparing the results between the groups, statistically non-significant
results were obtained in majority of the parameters suggesting that, both
Haritakyadi Kwatha (Trial drug) and VareeVidaryadi Kwatha (Control drug) had
equal effect in the management of Pittaja Mutrakrichra.Thus, from above
observation it was concluded that trial drug Haritakyadi Kwatha is as efficient as
the control drug VareeVidaryadi Kwatha in the management of Pittaja
Mutrakrichra with special reference to Lower Urinary Tract Infection .
However, based on effect size , oral administration of the trial drug
Haritakyadi Kwatha is more efficacious than the control drug VareeVidaryadi
Kwatha in the management of Pittaja Mutrakrichra.
LIMITATIONS OF THE STUDY
• The sample size of the study was small to draw conclusion for larger
population.
SCOPE FOR FURTHER STUDY
Recommendations on study design
• The study can be performed on a larger population to establish conclusive
results as there were promising results seen in the subjects taken for the
study.
Recommendations on drug form
• Further studies can be conducted by administering kwatha churna in tablet
form to improve palatability .
Recommendations on further evaluation of drug efficacy
• Anti-microbial activity to the specific micro-organisms found under urine
culture is to be carried out further to evaluate drug efficacy.
DATA ARCHIVE MAINTENANCE
• Confidentiality of the data will be maintained and the original raw data
would be preserved for the period of 5 years from the date of completion of
study.
CONTINUED CARE FOR SUBJECTS
• After completion of the trial duration, subjects were handed over to the
consultants of Department of Kayachikitsa with complete case history and
current clinical status of the subjects.
• Subjects were assured to provide continued health care facility and support
from the institution.
SUBJECT DRUG COMPLIANCE PROTOCOL
• All the subjects involved were ensured that they have taken medicine in
prescribed dosage. Follow-up was ensured through Telephonic contacts.
TRANSLATIONAL VALUES
• As promising results were observed in this study, Haritakyadi Kwatha
Churna can be made available in market by conducting clinical trial phases.
• Publishing the work in a peer-reviewed journal to reach out other clinicians
and supporting Evidence based practice.
• Dissertation would be available in the RGUHS library after approval and
would be accessible to interested scholars which promote therapeutic
utilization.