Summary

Title

A study on effect of chincha kshar along with varunadi kwath in the management of mutrashmari with special reference to renal calculus.

INTRODUCTION

Acharya Sushruta, the father of surgery has included Ashmari in Astamahagada due to its fatal nature.

Ashman the Sanskrit word, literally means structure resembling as stone. While the word Ari means enemy, so it refers to a sickness in which stones grow and inflict intense pain, as if caused by an adversary.

Mutrashmari can be associated with Urolithiasis which is the third most common affliction of the urinary tract. Aacharya Sushruta has described conservative treatment in the initial stage of the disease and advised that surgery to be done only on failure of conservative treatment and when death becomes inevitable if not operated.

Aacharya Chakra Datta mentioned that the Kshar along with Varunadi Kwath effectively cures the Mutra Vikaras like Mutrashmari, and its ingredients helps to cure Mutrasharkara, Mutrakruchha and Mutraghata.

According to Rasatarangini Chincha Kshar helps in overcome of Ashmari and Mutrakrricha.

The NAMC code of ASHMARI is EJ-2-

Nephrolithiasis is a global disease. Data suggest an increasing prevalence, likely due to Westernization of lifestyle habits (e.g., dietary changes, increasing body mass index). National Health and Nutrition Examination Survey data for 2007–2010 indicate that up to 19% of men and 9% of women will develop at least one stone during their lifetime. The prevalence is ~50% lower among black individuals than among whites. The incidence of nephrolithiasis (i.e., the rate at which previously unaffected individuals develop their first stone) also varies by age, sex, and race. Among white men, the peak annual incidence is ~3.5 cases/1000 at age 40 and declines to ~2 cases/1000 by age 70. Among white women in their thirties, the annual incidence is ~2.5 cases/1000; the figure decreases to ~1.5/1000 at age 50 and beyond. In addition to the medical costs associated with nephrolithiasis, this condition also has a substantial economic impact, as those affected are often of working age. Once an individual has had a stone, the prevention of a recurrence is essential. Published recurrence rates vary by the definitions and diagnostic methods used. Some reports have relied on symptomatic events, while others have been based on imaging. Most experts agree that radiographic evidence of a second stone should be considered to represent a recurrence, even if the stone has not yet caused symptoms.

Nephrolithiasis or urolithiasis are worldwide in distribution but are particularly common in some geographic locations like India. The peak incidence is observed in 2^nd to 3^rd decades of life. Renal calculi are characterized clinically by colicky pain (renal colic) as they pass down along the ureter and manifest by Haematuria.

Facts about Kidney Stones for Maharashtra (Pune) Residents. More than 1 in 10 people experience kidney stones in their lifetime. Around 50% chance of experiencing another stone within 5 years after the first occurrence. More common in individuals aged 30-60, and men are more prone to kidney stones than women.

In the context of India, Kidney stone disease is prevalent, with an expectancy of 12% in a total population reported to be prone to urinary stones. Of this 12%, the population are severely affected by renal damage, which even leads to a loss of kidneys. Unlike in South India, where a few reported percentages affected by Urolithiasis, in North India, there is a steep 15% of the population within the realm of Kidney stone disease. Thus, considering the prospects of the kidney stone belt, which are affected by Kidney stone disease in India, a proper corollary needs to be established. This stone belt occupies areas of Maharashtra, Gujarat, Rajasthan, Punjab, Haryana, Delhi, Madhya Pradesh, Bihar, and West Bengal. In these regions, the frequency of the prevalence and recurrence rate of renal stone is high in most of the members of a family.

 The incidence of urolithiasis is fairly high in South East Asia including several regions of India. In India, upper and lower urinary tract stones occur frequently but the incidence shows wide regional variation. The prevalence of urolithiasis is as high as 7.6% in Satpura part of Maharashtra with its multi factorial etiology and high rate of recurrences, urinary tract stone disease provides a medical challenge. It is important to know the chemical composition of stone as it is useful in advising people for taking preventive measures for reducing the risk of prevalence and recurrence can be considerably reduced by suitable reforms in diet and treatment regimen. We have evaluated clinical profile of patient with urolithiasis and analyse chemical composition of stone. We observe that in Pune city, many families have member afflicted with urolithiasis.

In this context, epidemiological studies are striving to elucidate the worldwide changes in the patterns and the burden of the disease and identify modifiable risk factors that contribute to the development of renal calculi which may end up to kidney damage or loss of kidney function.

Ayurveda is ancient science of life has explained various herbo-mineral remedies for various diseases. Chincha Kshar along with Varunadi Kwath in the management of Mutrashmari is one of them explained by Acharya’s in ancient text of Ayurveda which is easy to take, cost effective and affordable to all socioeconomic class.

In previous studies, Ashmarihara Kwatha, Kalyana Kshara, Gokshura Churna with honey, Apamarga Paniya Kshara, Gandharvhastyadi Churna the studies referred to indicated limited effectiveness in reducing symptoms such as renal colic pain, burning micturition, and hematuria, as well as in decreasing the size of the calculus. Furthermore, cost-effectiveness appears to be a consideration in assessing the overall efficacy of these interventions.

    The outcome from the previous study is clear that conservative treatment is also successful in treatment of Mutrashmari but none of the study has been conducted with Chincha Kshar  along with Varunadi kwath as Anupaan so this study is useful to prove efficacy of Chincha Kshar in treatment of Mutrashmari as well as cost effective.

HYPOTHESIS

  H₀ – CHINCHA KSHAR (Intake Orally) along with VARUNADI KWATH is not effective in the management of Mutrashmari and not effective in expulsion or disintegration of calculus.

  H₁– CHINCHA KSHAR  (Intake Orally) along with VARUNADI KWATH is effective in the management of Mutrashmari and is also effective in expulsion or disintegration of calculus.

AIM AND OBJECTIVES 

AIM

      To Evaluate the clinical efficacy of CHINCHA KSHAR  along with Varunadi Kwath in the management of Mutrashmari with special reference to Renal Calculus.

OBJECTIVES

To study the effect of CHINCHA KSHAR along with Varunadi Kwath to propulse the calculus downwards in urinary tract.

To study the effect of CHINCHA KSHAR along with Varunadi Kwath in the disintegration (size of calculus) of calculus.

3.    MATERIALS AND METHODOLOGY

MATERIALS

          Participants Details:- Participants having symptoms of Mutrashmari, visiting Bharati Vidyapeeth (Deemed To Be University) College Of Ayurved and Hospital will be recruited in the trial by following standard protocol.

            Drug :- CHINCHA KSHAR  will be used as study drug and VARUNADI KWATH will be used as Anupaan drug.                                                                      

             Study Type:- Clinical Trial

             Study Design:- The study will be Open-label single arm clinical trial

             Study site:-                OPD/IPD-Department Of Shalya

                 Bharati Vidyapeeth (Deemed To Be University)

                 College Of Ayurved And Hospital

                 Katraj; Dhankawadi, Pune (India)

Study Participants :- Participants presenting with signs and symptoms of Mutrashmari and fulfilling the following inclusion and diagnostic criteria will be enrolled in study

INCLUSION CRITERIA

  Participants having classical signs and symptoms of Mutrashmari are Jwara –fever (indication of urinary tract infection due to renal stone), Bastipeeda–pain in      hypogastric region, Aruchi –anorexia, Mutrakrichra–difficulty in micturition due to irritation of bladder by calculus and also infection caused due to it, Bastishirovedana–pain in suprapubic region, Kricchavsaad-bodyache with lethargic, Bastagandhatwam–concentrated urine smells like goat’s urine, Dushtasandramutrata –sedimentation of urine, Aavilamutrata–turbidity of urine. Mahativedana (intense pain), Sarudhiramootrata (During migration of stone from  urinary tract  injury  occurs, due  to  injury  haematuria occurs), Vedana in Nabhi, Basti, Sevani, Mehana pradesha and even in other regions (intense  pain at umbilical region, perineal region, suprapubic region, genitalia), Mootradharasanga (obstructed flow of urine), Mootravikirana, included.

  Paticipants having 50% of signs and symptoms will be present which are mentioned above included in study.

  Participants of calculus of age group (above 18 years) irrespective of gender and occupation is included.

  Participants having with or without mild hydronephrosis will be selected randomly. 

  Participants having calculus Size less than 8 mm. (Ureteric calculus)

  Participants having Renal Calculus upto 10mm-12mm.

DIAGNOSTIC CRITERIA

1      USG – Before treatment, after treatment and after 1month of trial

2      X-ray KUB (if required)

3      IVP –SOS

4      Urine examination – Routine and Microscopic.

5      Blood Urea, Serum Creatinine.

EXCLUSION CRITERIA

Participant below age of 18 years.

Pregnant women and lactating mothers.

Participants having Moderate or Severe Hydronephrosis.

Complications related to kidneys /ureter /bladder.

CRF, BPH, Urethral Stenosis/Stricture.

Participants having calculus more than size 8mm (Ureteric calculus)

3.7)          SAMPLE SIZE

Sample Type/ Sampling Method: Purposive Sampling

Incidence available of Mutrashmari. According to the data available in the Bharati Ayurved Hospital, the prevalence rate of Mutrashmari is 6.7%. 

Sample size calculation

 N =Z2P(1-P)/D2

= (1.96)² x 6.7(1-6.7) / (0.05)²

= 3.8416 x 0.067 (1-0.067) / 0.0025

= 3.8416 x 0.067 x 0.933 / 0.0025

= 0.24 /0.0025

= 96

Total 100 patients will be enrolled for the study.

Where N = Sample Size, P = Prevalence, Z = Standard Normal Value, D = Error

3.8)          INTERVENTION  

Group  (Trial group) – CHINCHA KSHAR 500 mg (Paneeya kshar) along with Varunadi Kwath 40ml half an hour before morning and night meal (intake orally).dose decided as mentioned in r. t. 14/64   

Kshara Dose– 2-8 gunja and from the reference from AFI the dose of CHINCHA KSHAR is decided on the basis of different therapeutic dose of Kshar which are mentioned in AFI,

r. t. 14/64 and essential drugs list (EDL) Ayurveda by department of Ayush (Drug Control Cell) Ministry of Health and Family Welfare Government of India March 2013.

The drug will be given for a duration of 15 days which has been previously established by various expertise on the basis of clinical skills.

Follow-ups will be taken periodically on day 1^st, 5^th, 10^th, 15^th of the study.

METHODOLOGY

PROCUREMENT, AUTHENTIFICATION AND STANDARDIZATION -

Chincha Panchanga will be purchased from the reliable sources, authenticated at appropriate authorities and standardized prior to use in the study. The Kshar will be prepared as mentioned in classics. Formation of drug in powder form and will be stored in air tight containers.

PROCUREMENT, AUTHENTIFICATION AND STANDARDIZATION -

Varunadi Kwath contents will be purchased from the reliable sources, authenticated at GMP certified Pharmacy/Laboratories. The Kwath will be prepared as mentioned in classics with standard protocol according to API parameters. Kwath will be standardized prior to use in the study. The Kwath will be in powder form and will be stored in air tight containers.

3.9)          TRIAL METHODOLOGY

  The study will be conducted after obtaining due permission from the Institutional Ethical Committee and will be registered in CTRI, India.

  Patient will be selected randomly on the basis of inclusive/exclusive criteria

  Whole research procedure and aim of the study will be clearly informed to patients and informed consent will be taken and CRF will be filled {ANNEXURE III & ANNEXURE IV}.

  Once patient is enrolled having symptoms of Mutrashmari selected from OPD and IPD of Shalya Tantra dept. of B.V.D.U.C.O.A & hospital will be taken.

  Clinical evaluation will be done by collection of data through information obtained by history, physical examination and laboratory investigation wherever necessary. Case study Performa will be provided to the patients. ANNEXURE IV

  Follow Up will be done (0^th, 5th, 10th, 15th day). If any side effects observed it will be managed with appropriate standard medications.

  Patient will be observed for reduction of Renal Colic Pain, Burning Micturition, Haematuria, Effect of drug and Size of Calculus before starting and after completion of treatment. Investigations – USG – Before treatment, after treatment and after 1 month follow up USG, X-ray KUB, Urine examination – Routine and Microscopic, Blood Urea, Serum Creatinine before treatment, IVP –SOS.

  Patient will be telephonically connected with the researcher if any complications occur during the trial as an outcome of the research purpose all the possible care will be taken by the hospital till the patient is normalized.