A randomised 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.

This study is put forward to evaluate the efficacy of Haritakyadi Kwatha  in the management of  pittaja mutrakrichra with special reference to lower urinary tract infection in comparision with VareeVidaryadi Kwatha.

HYPOTHESIS:

1.Null Hypothesis (H0 ) = The  efficacy of Haritakyadi Kwatha  do not differ from the efficacy of VareeVidaryadi kwatha in the management of pittaja mutrakrichra with special reference to lower urinary tract infection.

2.Alternative Hypothesis(H1 ) = The efficacy of Haritakyadi Kwatha  is different from the efficacy of VareeVidaryadi kwatha in the management of pittaja mutrakrichra  with special reference to lower urinary tract infection.

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.