The present dissertation entitled “A Clinico-Comparative Study of varunadi ghanvati and eladi ghanvati for the modulation of serum calcium level and Management of MÅ«trāśmarÄ« W.S.R. To Urinary Calculus” is a clinical study to know efficacy and effectivity of varunadi ghanvati & eladi ghanvati, carried out in the department of kayachikitsa at academic hospital IPGT & RA, Jamnagar. The present work consists of the following five chapters.

INTRODUCTION:

Urolithiasis is a chronic urinary and systemic disorder, which is directly related to serum calcium concentration as well. However, it is manageable with a proper line of conservative and surgical treatment. According to ashtanghridaya, taruna (primary urolithiasis without any systemic disease or any complication) must be treated with medical treatment but, if it is pravrudhha(chronic with complications), the surgical management must prefer. The first line of treatment must be conservative if there are no emergence consequences.

It is the third most common affliction of the urinary tract, exceeded only by UTI and BPH. The process of forming stones in the urinary tract i.e., kidney, bladder and ureter is referred to as ‘urolithiasis’. Due to any disease or idiopathic pathology increased serum calcium level is directly related to forming the stones. Hypercalcemia referred to more calcium filtration through urine, when urine becomes supersaturated with insoluble materials due to increased excretion and/or because of extreme water conservation, crystals form and may grow and aggregate to form calculi. Most patients with nephrolithiasis have calcium-containing stones. A significant number of such stone formers have increased urinary calcium excretion, but a minority has a systemic disease-causing chronic hypercalcemia and the promotion of stone formation. Urolithiasis is the topmost complication of hypercalcemia. The serum calcium level should be measured in all patients with stones. Although the vast majority has a normal value, those who have elevated serum calcium levels must be identified not only to prevent further urolithiasis but also because of the implications for other organ systems. Gujarat is covered in stone belt areas for calcium stones. In Gujarat, particularly in the saurashtra region, the incidence of the disease urinary stone is very high due to the high mineral content of water and hot climate. Nine million (90 lacs) people of the population are expected to have urinary stones with new cases adding each year.

Around Fifty percent of patients may end up with kidney or renal damage. Kidney stones are common among people from saurashtra and in western Gujarat due to the high level of total dissolved salts (TDS) in water. About 30% patients of with urinary disorders are found suffering from urolithiasis. The chemical composition of urinary stones in children is like those found in adults. About one-half are calcium oxalate, calcium phosphate account for 15–25%, while 10–15% is mixed (calcium oxalate and calcium phosphate). The others are struvite (magnesium ammonium, phosphate) 15–30%, cystine 6–10%, and uric acid 2–10 %. The best line of management can be discovered in the Ayurveda classics for the modern days’ urolithiasis management, as surgical treatment comes with its complications and for a country like India where there is a higher number of patients of urinary calculus, every patient can not have a gold standard conventional management for urolithiasis. Successful management of urinary calculus by Ayurveda can decrease the surgical incidence of urinary calculus.

CONCEPTUAL STUDY:

Relevant materials from various samhitas and other texts were compiled. Various journals, publications, and websites containing appropriate materials were also searched and compiled. Compilation of literary material from Ayurvedic and Modern concepts are completed. Compilation of information on drugs from various research sources is completed. Ayurveda research drugs with their rasapanchaka & prabhava were analyzed along with their mode of action on disease pathologies. Active principles of the research drugs were analyzed according to the modern way of research to justify its actions for the management and prevention of the disease.

PHARMACOGNOSTICAL STUDY:

The Pharmacognostical study comprises of organoleptic study and microscopic study of the finished product. The organoleptic characteristics of Ayurvedic drugs are very important and give a general idea regarding the genuineness of the sample. Organoleptic parameters like taste, colour, odour, and touch were scientifically studied. For Group A, in the microscopic study, varunadi ghanvati was powdered and dissolved separately with water and microscopy of both the samples were done without stain and after staining with Phloroglucinol + HCL. Microphotographs of varunadi ghanvati were also taken under a Corl-ziesstrinocular microscope. For Group B, in the microscopic study, eladi ghanvati was powdered and dissolved separately with water and microscopy of both the samples were done without stain and after staining with Phloroglucinol + HCL. Microphotographs of eladi ghanvati was also taken under a Corl-ziesstrinocular microscope.  This study has been carried out in the pharmacognosy laboratory, I.P.G.T & R.A. Gujarat Ayurved University, Jamnagar under expert guidance.

PHARMACEUTICAL STUDY:

The physicochemical constants like pH, variation in weight, hardness, disintegration time, results of TLC photo documentation, the unique Rf values and densitogram obtained at different wavelengths can be used as fingerprints to check the quality of varunadi ghanvati and eladi ghanvati . Physio‐chemical studies were carried out as per WHO guidelines, Ayurvedic Pharmacopoeia, and Indian Pharmacopoeia for Standardization of varunadi ghanvati and eladi ghanvati . This study has been carried out in the pharmaceutical laboratory, I.P.G.T & R.A. Gujarat Ayurved University, Jamnagar under expert guidance.

MICROBIOLOGICAL STUDY: 

Microbial contaminations may ultimately contribute to secondary bacterial infections in patients. So, microbiological studies of the final product of both the drugs are completed in the microbiological lab. There are no microorganisms and fungal filaments seen.

CLINICAL STUDY:

The study design of the present clinical trial was Clinico-comparative, interventional single-blind randomized controlled trial. The clinical study was started after the approval of IEC (vide PGT/7/-A/Ethics/2017-18/3042 dated 19/02/2018. The trial is also registered in CTRI prospectively with registration number CTRI/2018/05/014168 dated 29/05/2018. In the present clinical trial, approximately 66 Patients complaining of ruk (pain), mootradaha (burning micturition), sarakta mootrapravrutti (haematuria), mootrakruchhra (dysuria) etc. fulfilling the criteria of inclusion and giving their consent to participate in the clinical study were selected irrespective of their sex, religion, occupation caste etc. from OPD and IPD Kayachikitsa of I.P.G.T. & R.A Hospital, Gujarat Ayurved University, Jamnagar. They were randomly divided by a computer-generated randomization chart into two groups Group-A varunadi ghanvati and Group-B eladi ghanvati . Out of 66 patients, 64 patients completed the full course of the trial, and 2 patients did not complete the trial period because of personal reasons.

RESULTS:

After 8 weeks of intervention, significant results (P<0.05) were observed statistically in both groups (group A & group B) in reducing subjective (signs and Symptoms) and in objective assessment parameters like (Urine routine and microscopic, USG KUB (in Stone size and numbers)). In this study, for the modulation of S. Calcium levels, both the drugs have a significant effect on it. Haematological and biochemical investigations i.e., Hb%, U. Albumin and other urine routine and microscopic parameters were within normal range. As per the results for the individual group, both the drugs have a significant effect on the management of urinary calculus and modulation of S. Calcium levels. In the statistical analysis of intergroup comparison, there were not statistically as well as clinically, significant results observed in the management of urinary calculus. These results suggest that for the individual group null hypothesis is rejected as we have found significant effectivity of both the drugs, while for intergroup comparison no drug had more significance than the other drug. Thus, for this parameter null hypothesis is accepted. Also, no recurrence of the disease was found in follow-up. No Adverse drug reaction was noted during the study period and in follow up.

THE OVERALL EFFECT OF THERAPY:

In group A, complete remission (Cured) was not observed in any of the patients. Marked improvement was observed in 12 (37.50%) patients. Moderate improvement was observed in 20 (62.50%) patients. There was no patient presented with mild, or no improvement in this group.

 In group B, complete remission (Cured) was not observed in any of the patients. Marked improvement was observed in 07 (21.88%) patients. Moderate improvement was observed in 25 (78.13%) patients. There was no patient presented with mild, moderate or no improvement in this group.

CONCLUSION FOR HYPOTHESES:

FIRST RESEARCH QUESTION:

(1) Do varunadi ghanvati and eladi ghanvati have a significant effect in the modulation of s.calcium level and/or treatment of urinary calculus? 

 ACCEPTED ALTERNATE HYPOTHESIS (H₁):

u  varunadi ghanvati and eladi ghanvati have a significant effect in the modulation of s.calcium level and treatment of Urinary calculus.

SECOND RESEARCH QUESTION:

(2) Do varunadi ghanvati and eladi ghanvati have equal effects in the modulation of s.calcium level and/or treatment of Urinary calculus?

ACCEPTED NULL HYPOTHESIS (H₀):

u  varunadi ghanvati and eladi ghanvati have equal effects in the modulation of s.calcium level and/or treatment of Urinary calculus.