Role of patala kshara and gokshuradi choorna in renal calculi – a clinical study

Rabinarayan Tripathy; Shanu K Babu; PN Rajeshwari; Shaithya Raj; Susmita Priyadarshinee Otta

doi:10.4103/joa.joa_175_20

ORIGINAL ARTICLE

Year : 2021 | Volume : 15 | Issue : 4 | Page : 255-260

Role of patala kshara and gokshuradi choorna in renal calculi – a clinical study

Rabinarayan Tripathy¹, Shanu K Babu¹, PN Rajeshwari¹, Shaithya Raj¹, Susmita Priyadarshinee Otta²
¹ Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri Campus, Amrita Viswa Vidyapeetham, Kerala, India
² Research Officer, Central Research Institute for Hepatobiliary Disorder, CCRAS, Bhubaneswar, Odisha, India

Date of Submission	01-Oct-2020
Date of Decision	11-Dec-2020
Date of Acceptance	29-Jul-2021
Date of Web Publication	16-Dec-2021

Correspondence Address:
Rabinarayan Tripathy
Department of Shalya Tantra (Surgery), Amrita School of Ayurveda, Amritapuri, Amrita Vishwa Vidyapeetham, Kollam, Kerala
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/joa.joa_175_20

Abstract

Background: Renal calculi or kidney stone disease is a common painful urologic disease causing significant social and financial burden. It has high recurrence rate of nearly fifty (50%) percentage. Ayurveda textual references mention specific diuretic, lithotriptic medicines for Asmari (Renal Calculi) which can provide safe, effective and economical treatment. Aim: To evaluate the combined efficacy of Patala kṣhara (an alkaline powder prepared from ash of Stereospermum chelonoides) and Gokshurdi churna (herbal powder) in the disintegration and expulsion of renal calculus. Materials and Methods: The study was a pre and post clinical trial with 30 patients in a single group selected on the basis of specific inclusion and exclusion criteria (Ultrasonography [USG] evidence of renal calculi up to 8 mm size). They were imparted 500 mg Paṭala kshara capsule with lukewarm water and 6 g Gokshuradi churna with honey internally twice daily after food for a period of 30 days. Assessment were done on 15^th, 30^th and 60^th day for subjective parameters (pain, haematuria, burning micturition and increased frequency of micturition) and on 30^th day for objective parameters like size and number of stones and epidermal growth factor receptor. Results: Pain, dysuria, size and number of calculus is statistically significant with P < 0.000. Haematuria showed significance with P < 0.046, burning micturition and increased frequency of micturition were significant with P < 0.008. Conclusion: On analysing the results it can be concluded that Patala kshara and Gokshuradi churna are effective in disintegrating and expelling renal calculus. It is effective in reducing the size and number of stones as well as the clinical symptoms.

Keywords: Asmari, Gokshuradi churna, Patala kshara, renal calculi

How to cite this article:
Tripathy R, Babu SK, Rajeshwari P N, Raj S, Otta SP. Role of patala kshara and gokshuradi choorna in renal calculi – a clinical study. J Ayurveda 2021;15:255-60

How to cite this URL:
Tripathy R, Babu SK, Rajeshwari P N, Raj S, Otta SP. Role of patala kshara and gokshuradi choorna in renal calculi – a clinical study. J Ayurveda [serial online] 2021 [cited 2022 Jan 27];15:255-60. Available from: http://www.journayu.in/text.asp?2021/15/4/255/332600

Introduction

Renal calculus or kidney stone disease is one of the oldest and most common urological disorders affecting 12% of the Indian population.^[1] It is a global disease, and the prevalence is increasing throughout the industrialized world, likely due to the westernization of lifestyle habits (e.g., dietary changes, increasing body mass index), Diabetes Mellitus, and global warming. National Health and Nutrition Examination Survey data for 2007–2010 reports that up to 19% of men and 9% of women develop at least one stone during their lifetime.^[2] It has a recurrence rate of about 50% or more after the initial stone episode.

Urinary stones are polycrystalline concretions occurring in the urinary tract. Though it has a multifactorial etiology, the main cause for all stone formation is the supersaturation of urine either due to increase in solvents in urine or due to decrease in urine volume.^[3] It can occur in any age, but the maximum incidence (approximately 50%) is found in between 30 and 50 years.^[4] Stones do not necessarily produce symptoms. Asymptomatic stones may be incidentally found during the course of radiographic studies undertaken for unrelated reasons. Pain and hematuria are the leading symptoms of stone disease.^[5] Treatment of urinary lithiasis is dependent on the size and location of the stone in addition to the severity of symptoms associated with the stone.

Surgical advancement has mainly focused on the removal of existing stones, and usually small stones are left as such, which can act as nidi for new stone. Modern management measures are either expensive or with side effects. Complications include hemorrhage from the punctured renal parenchyma, perforation of collecting system, colon or pleural cavity, ureteric colic, fragment impaction, and infection.^[5]

In Ayurveda, it is described as Asmari. It is enumerated as one among Asta Mahagada (eight diseases that difficult to cure). In persons who do not follow purification treatments, indulge in unwholesome food and activities, Kapha Dosa gets aggravated, saturates the urine and produces stones.^[6] Acharya Sushruta has mentioned various medications in the form of Ghrita (medicated Ghee), Kshara (alkalis), Kashaya (Decoction), Kshira (milk preparations), and Uttarabasti (douche applied through urethra) for the treatment of Asmari. If disease does not get alleviated, surgery is the ultimate treatment. Ayurveda textual references mention many diuretic, lithotriptic medicines which can provide safe, effective treatment and can cure renal calculi in the initial stage. In Astanga samgraha Asmari Chikitsa, a preparation including Paṭala kshara and Gokshuradi churṇa is praised for its Asmari bhedana (splitting) and chyavana (eliminating) property.^[7]

Aim

The aim of this prospective study was to evaluate the combined efficacy of Patala Kshara (an alkaline powder prepared from ash of Stereospermum chelonoides) and Gokshuradi Churna (herbal powder) in the disintegration and expulsion of renal calculus, with an objective to provide safe, economical, and effective management of renal calculus.

Materials and Methods

This was a pre- and post-clinical study with Clinical Trial Registry of India, registration number: clinical trials registry-India/2018/02/012152. The study protocol was approved by the Institutional Ethics Committee at Amrita Institute of Medical Science, Cochin, Kerala, India (IEC-AIMS-2017-AYUR-262). Thirty patients were selected after initial screening and investigations to fulfill the inclusion criteria.

Inclusion criteria

Patients between 20 years and 60 years of age irrespective of sex, religion, occupation, and socioeconomic status
Evidence of renal calculi by X-ray KUB/USG
Calculi up to 8 mm size.

Exclusion criteria

Calculi size more than 8 mm
Case of immediate surgical intervention
Patients of renal calculi with complications like severe hydronephrosis, Glomerular nephritis, and chronic renal failure
Patients with systemic illness such as TB, HIV, Hepatitis-B, venereal disease research laboratory (VDRL), and renal carcinoma
Paneeya kṣāra anarhas (where alkali intake is contraindicated)
Pregnant women.

All the patients were informed about the treatment, and prior written consent was obtained. The medicines were prepared by following the AFI guidelines, and the quality was checked in the QC lab of Amrita School of Ayurveda. Organoleptic and physico-chemical characters of the trial medicines were analysed. Thirty patients selected for the study received Patala Kshara, 500 mg capsule with lukewarm water, and Gokshuradi Churna in the dose of 6 g with honey, twice daily after food for a period of 30 days. The patients were advised to follow dietary regimen of Aśmarī.

Assessment criteria

Periodic clinical assessments were done on 0^th, 15^th, and 30^th day. Follow-up was done on 60^th day.

Pain: Pain due to renal calculi was assessed by the "Visual Analogue Scale" on a numeric scale of 0–10.

Haematuria, burning micturition, and increased frequency of micturition were analyzed by its absence and presence with Grades 0 and 1, respectively.

The clinical assessment of dysuria was done by dysuria discomfort scale grading extract from Boyarsky score from 0 to 3.^[8]

Size of renal calculi:-USG of abdomen and pelvis was done to assess the change in size and number of stones. Renal calculi size up to 8 mm assessed through USG. If 2 or more calculi were present in a subject, the mean size was taken to evaluate the size reduction. The numbers of stones were recorded as per the USG report. Single, double, and multiple stones were reported and were given 1, 2, and 3, respectively. In cases of bilateral kidney stones, a total number of stones in both kidneys was taken together.

Epidermal growth factor receptor (eGFR)-was also assessed to know the kidney function. It was checked online by providing the age, gender, and serum creatinine values of the patients.^[9]

Trial drug

Raw drugs procured from the local market were identified and certified by the Taxonomist, Department of Dravyguṇa, Amrita School of Ayurveda. There were two trial drugs, namely, Patala Kshara and Gokṣuradi churna.

Preparation of Patala Kshara

The stem and root of Paṭala (Stereospermum chelonoides DC Linn) tree were collected. It was cut into small pieces, dried completely, and burnt in an iron vessel. The pieces were added little by little into the fire and ash was obtained. From this ash, kshara was prepared in the Rasashastra lab, Amrita School of Ayurveda, by following the standard Kshara preparation procedure. One part of ash was rubbed and mixed well with 6 parts of clean water in a stainless steel vessel and kept undisturbed overnight. On the next day, the saturated water was filtered through four folded clean white muslin cloth, and the sediments at the bottom of vessels were discarded. This process of straining was continued for 21 times till a colorless liquid is obtained. The clear solution thus obtained was evaporated on moderate flame in an iron vessel. The color of ksharajala (alkaline water) changed to yellowish and gradually brownish as the temperature rose. Finally, when water evaporated completely, solid salty white colored kshara (Alkaline Powder) was obtained. It was dried well by keeping in hot air oven and stored in an air tight glass bottle.

Preparation of Gokshuradi churna

The ingredients mentioned in [Table 1] were thoroughly cleaned, dried, finely powdered and sieved. Equal quantities of each drug were well mixed together and stored in an airtight container [Table 1].

Table 1: Ingredients of gokṣuradi cūrṇa

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Statistical analysis

The data corresponding to the values of various assessments, before and after treatment of 30 patients excluding dropouts were taken for statistical analysis using SPSS ver 20 (IBM Corp., Armonk, N.Y., USA). The result of treatment was analysed through Wilcoxon Signed Rank Test for subjective parameters like pain, haematuria, burning micturition, dysuria and increased frequency of micturition, to interpret the significant changes. Paired t-test was done to assess significant changes of objective parameters like size and number of calculus and eGFR, before and after treatment.

Results

In this study group, based on Wilcoxon Signed rank test, after treatment all the subjective parameters like pain, haematuria, burning micturition, dysuria and increased frequency of micturition showed a significant result [Table 2].

Table 2: Effectiveness of treatment on clinical signs and symptoms

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The pain reduced from BT mean of 1.67–0.63 on 15^th day assessment, 0.1 on 30^th day and on 60^th day follow up [Figure 1

Figure 1: Mean reduction on clinical signs and symptoms

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] with P < 0.0001. Mean grade for haematuria BT was 0.13 which remained 0 on 15^th, 30^th, and 60^th days of assessment. The mean value of burning micturition was 0.23 before treatment. After treatment, the mean reduced to 0.03 on 15^th day and became 0 on 30^th and 60^th days of assessment. Dysuria reduced from BT mean of 0.63–0.1 on 15^th day assessment, 0.03 on 30^th day and on 60^th day follow up with P < 0.0001. Mean grade for increased frequency of micturition before treatment was 0.23, which reduced to 0.06 on 15^th day, came to 0 on 30^th day and persisted in the follow-up on 60^th day.

The mean number of calculi BT was found to be 1.96, and on 30^th day, it became 0.93 with a mean difference of 1.033. The paired t-test for size of calculi was statistically significant with P < 0.0001. The mean size of kidney stones before and after treatment was 4.52 and 2.97, respectively, with a mean difference of 2.192. The statistical analysis shows a significant result with P < 0.0001. The mean eGFR before treatment was 104.5, and after 30 days of treatment, it changed to 107.6 and the mean difference was 3.133. The eGFR got improved with 30 days of treatment. After statistical analysis with paired-t, the result was statistically significant as the P < 0.001 [Table 3].

Table 3: Paired t-test for objective parameters

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Discussion

The study was mainly aimed to assess the efficacy of Patala Kshara and Gokshuradi Churna in the disintegration and elimination of renal calculi in 30 patients for a treatment period of 30 days. After USG KUB taken on 30^th day, it was found that 12 out of 30 patients got completely cured from renal calculi. The number of stones got reduced in 11 subjects and remained same in six patients. In one patient, the number got increased, as the single large stone might split to form 2 stones. But the mean size was reduced in this case. It denotes the disintegrating property of the trial drug. The mean size of calculus got reduced in 27 subjects after 30 days of treatment.

The subjective parameters like haematuria, burning micturition and increased frequency got completely cured after treatment. Pain got reduced in all patients after 30 days. Among the 27 patients presented with pain, 24 got cured, and mild pain remained in three patients. Fifteen out of 16 patients who had the complaint of dysuria at the time of screening got cured after treatment. Pain, dysuria, size, and number of calculus was statistically significant with P < 0.000. Hematuria showed significance with P < 0.046, burning micturition and increased frequency of micturition were significant with P < 0.008. On analysis of the results, it was found that Patala Kshara and Gokshuradi Churna was effective in reducing the size and number of stones in the kidney along with reduction of clinical symptoms. Even though eGFR was not a parameter to assess the effect of drug on renal calculi, it was assessed to see whether the alkali preparation used in the study have caused any reduction in kidney function.

As per Acharya Sushruta, kapha predominant tridoṣa is involved in Asmari formation. So, measures that pacify tridoṣa mainly to mitigates kapha, has been adopted in the present study.

The formulation Gokshuradi Churna contains five ingredients, namely, Gokṣura, Ela, Trapuṣa, Kuraṇṭaka and Pasaṇabheda. By analyzing the pharmacological action of individual drugs, they were proven to possess diuretic, anti-urolithiatic, anti-spasmodic, anti-inflammatory and anti-nociceptive properties. The diuretic activity of Tribulus terrestris is due to large quantities of nitrates and essential oil present in the fruits and seeds.^[10] A novel antilithiatic protein having cytoprotective potency was isolateded from Tribulus terrestris.^[11] Quercetin and kaempherol present in Tribulus terrestris not only has the potential to inhibit nucleation and growth of calcium oxalate crystals but also has a cytoprotective role. It also inhibits the activity of glycolate oxidase, which is the principal enzyme involved in oxalate synthesis. It also possesses anti-inflammatory, analgesic, and antispasmodic action.^[12] Studies have proved that extract from the seeds of cardamom exhibited diuretic and antispasmodic property.^[13] Cucumis sativus seeds help in diuretic activity by regulating Renin–Angiotensin pathway.^[14] Studies on Barleria prionitis proved that the drug possess analgesic, anti-inflammatory and anti-nociceptive activity. Paṣaṇabheda (Rotula aquatica) also is effective in decreasing the urolithiasis.^[15] From the Ayurveda point of view, drugs of Gokshuradi Churna possess Mutrala (diuretics), basti shodhana (that disinfects bladder), Asmari nashana (lithotriptic) and tridoṣahara properties. The formulation is predominant in laghu guna (property of making lightness) which helps to reduce kapha. Four drugs in the formulation have seeta virya (cooler potency) which may reduce the burning sensation of Asmari. Vatanulomana (that initiates evacuation), Mutrala (diuretics) and Sothahara (anti-inflammatory) property helps to relieve pain. Rasayana (rejuvenating) property of Gokshura helps in overall improvement of health.

Kshara are alkaline substance extracted from the water soluble ash of drugs. In Ayurveda, kshara is considered as supreme among all Surgical and Para surgical measures due to its chedya (excising), bhedya (puncturing), lekhya (scraping), and tridoṣahara property and can be employed for treating specific conditions. Kshara results in the elimination of aggravated doṣas in the basti (Urinary bladder) because of its cleansing and corrosive property.

Patala Kshara having a pH of 10.6; it may alter the urinary pH, lowers the urine saturation, reduces calcium oxalate crystallization and helps in the dissolution of calculus. Due to its chedana, bhedana and sodhana property, it can reduce the size, disintegrates and eliminate calculus. The Ushna, Tikshna property of Kshara helps to break Kshara Sanghata, thereby reducing the pain. Ropana property of Kshara helps in reducing the haematuria. Vatasamaka property of the drug normalises the function of Apana vayu and helps in expulsion of stone.

Conclusion

The trial drug was found to be effective in the disintegration and expulsion of renal stone and in reducing the size of the stone irrespective of its type. No adverse events of the drug were noted during the course of treatment. Hence Patala kshara and Gokshuradi churna can be used as another safe and effective treatment modality in case of renal calculi independent of its type.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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