E-ISSN:2456-3110

Research Article

Mutrashmari

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 9 October
Publisherwww.maharshicharaka.in

A controlled clinical trial to evaluate the efficacy of Kulatthadi Ghrita in the management of Mutrashmari vis-à-vis Urolithiasis

Hebballi P.1*, Hegde G.2, Guled S.3
DOI: http://dx.doi.org/10.21760/jaims.7.9.5

1* Priyanka Hebballi, 3rd Year Post Graduate Scholar, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India.

2 Gajanana Hegde, Professor, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India.

3 Siddram Guled, Assistant Professor, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India.

Mutrashmari is one of the most common conditions of Mutravahasrotas. The word Ashmari in Sanskrit denotes the stone or calculi and Mutra means urine. Mutrashmari is characterized by formation of stones anywhere in urinary tract. It is a dreadful condition and has potential to disturb the anatomy and physiology of the urinary system. Once it formed in the body it tends recurrence thus get difficult to cure. Hence it is included under Ashtamahagada. In modern medical system it is correlated with urinary calculi or Urolithiasis based on signs and symptoms. Factors such as diet, water, climate, geographical conditions will also play major role in causing Mutrashmari. Ayurveda basically aims at prevention of formation of Mutrahmari along with braking and flushing of existing calculi. In Ayurveda texts administration of oral medication in different forms such as Ghrita, Kshara, Kashaya and other Shamanousadhi, Shodhana Karma and Shastra Karma are emphasized for management of Mutrashmari. Snehapana is the basic principle in the management which is to be adopted in primary stage of Mutrashmari. In the present study Kulatthadi Ghrita having properties such as Ashmaribhedana, Ashmari Patana and Mutrala activities has been taken up as indicated in Chakradatta for Ashmari, along with Nagaradi Kashaya and Badarashma Pishti.

Keywords: Mutrashmari, Mutravahasrotas, Kulatthadi Ghrita, Urolithiasis

Corresponding Author How to Cite this Article To Browse
Priyanka Hebballi, 3rd Year Post Graduate Scholar, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India.
Email: 		Priyanka Hebballi, Gajanana Hegde, Siddram Guled, A controlled clinical trial to evaluate the efficacy of Kulatthadi Ghrita in the management of Mutrashmari vis-à-vis Urolithiasis. J Ayu Int Med Sci. 2022;7(9):36-42.
Available From
https://www.jaims.in/jaims/article/view/2073

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-08-30 2022-09-01 2022-09-08 2022-09-15 2022-09-22
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 16%

© 2022by Priyanka Hebballi, Gajanana Hegde, Siddram Guledand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

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Hebballi P et al: Kulatthadi Ghrita management of Mutrashmari vis-à-vis Urolithiasis

Introduction

Mutrashmari is a very common worldwide problem, troubling mankind since ages and is one among the major reason for abdominal pain these days. It is Kaphapradhana Tridoshaja Vyadhi and included under Ashtamahagada[1] because of its Marmashrayatwa[2] and various complications caused by the disease. Considering its clinical symptoms, Mutrashmari is compared to Urolithiasis. Urolithiasis is the third most common affliction of urinary tract after urinary tract infections and benign prostatic hypertrophy.[3]

There are different treatment modalities available in different systems of medicine such as flush therapy for stones less than 5mm and surgical procedures for larger stones. But they are quite expensive and pathogenesis behind the formation of calculi cannot be avoided. Even surgical methods available for the management of calculi such as ESWL, ureteroscopy, percutaneous nephrolithotomy etc.[4] also fail to prevent recurrence and have got many complications such as sepsis, strictures etc. hence there is need for alternative treatment modalities which is cost effective and having very less or no complications. A number of Ayurvedic formulations have been used since past for managing Mutrashmari. One among such formulation is Kulatthadi Ghrita.[5] Present study was conducted with the objective to evaluate the efficacy of Kulatthadi Ghrita in the management of Mutrashmari vis-à-vis Urolithiasis.

Materials and Methods

The formulations used in the study i.e., Kulatthadi Ghrita and Nagaradi kashaya were manufactured by S.N. Pandit and son’s Co. Pvt. Ltd, Mysuru, (a GMP certified pharmacy) were procured for the purpose of study. Badarashma Pishti manufactured by Shree Dhutapapeshwara Ltd. (a GMP certified pharmacy) was procured from available marketing sources for the purpose of study.

Study design: Double arm open labeled controlled clinical trial with pre and post-test study design.

Simple random sampling technique was employed.

The subjects fulfilling the diagnostic criteria of Mutrashmari vis-à-vis urolithiasis were assigned in two groups viz., Group A and Group B.

Total of 45 subjects, of Mutrashmari via-a-vis Urolithiasis were randomly selected from OPD and IPD of Government Ayurveda Medical College, Mysuru and registered for the study. There were 22 subjects registered in Group A and 23 in Group B. by the end of the study there were 5 dropouts at different stage of the study. The study was completed in 40 subjects, 20 subjects in each group. The details of intervention is given below.

Table 1: Showing intervention in Group A and Group B

Group A 1. 30 ml of Nagaradi Kashaya[6] with equal quantity of water, 350 mg Yavakshara and 3gm of Guda three times a day before food 2. 250 mg of Badarashma Pishti[7] with honey as Anupana, three time a day before food.
Group B 1. 12gm of Kulatthadi Ghrita was administered with warm water as Anupana, before food, 2 times in a day. 2. 30 ml of Nagaradi Kashaya with equal quantity of water, 350 mg Yavakshara and 3gm of Guda three times a day before food 3. 250 mg of Badarashma Pishti with honey as Anupana, three time a day before food.
Duration of the intervention 30 days

Inclusion criteria

1. Subjects of 18-60 years of age group irrespective of gender, caste, religion were included in the study.

2. Both fresh and treated cases were taken for the study.

a. Definition of fresh cases includes freshly detected and untreated cases of Mutrashmari vis-à-vis Urolithiasis.

b. Definition of treated cases includes, already diagnosed and registered cases of Mutrashmari vis-à-vis Urolithiasis, who had voluntarily discontinued the treatment included with flush out period of 7 days, were included.

3. Subjects with or without clinical features of Mootrashmari diagnosed with presence of urinary calculi (solitary or multiple) by radiological examination measuring 4-8mm anywhere in (KUB) kidney, ureter, and bladder were included in the study.

Exclusion criteria

1. Subjects with acute symptoms like severe nausea and vomiting were excluded.


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Hebballi P et al: Kulatthadi Ghrita management of Mutrashmari vis-à-vis Urolithiasis

2. Subjects with impaired renal function, renal failure, renal obstruction, severe hydronephrosis, and complications needing emergency surgical interventions were excluded.

3. Subjects with association of any other severe systemic disorders that may interfere with the present intervention.

4. Subjects suffering from severe hematuria were excluded.

5. Pregnant and lactating women were excluded.

Diagnostic criteria

Diagnosis was made on the basis of ultrasonography or CT of Kidney, Ureter, Bladder (KUB) and clinical symptoms.

Assessment parameters

In the present study the assessment was carried out in the following schedule:

1. Pre test assessment was done on 0 day before the commencement of intervention.

2. Post test assessment was done on 31st day after the completion of intervention.

Data was collected according to case sheet proforma which was specially designed for the purpose of the study.

Observations and assessment were done based on both subjective and objective parameters.

Subjective parameters with gradating index included Bastishoola, Mutradaha, Saraktamutrata and Mutrakrichra.

Objective parameter included USG of KUB region.

Both Subjective and objective parameters were assessed before intervention (0 day) and after intervention (31st day).

Primary assessment parameters

1. Ultrasonography of abdomen and pelvis were done before the beginning of intervention and after the completion of intervention. Following parameters were assessed

  • Number of stones.
  • Size of the stone.
  • Site of the stone.


Secondary assessment parameters

Table 2: Showing assessment parameters

Shula in Nabhi (umbilical region), Basti (supra pubic region), Sevani (perineal region), Mehana (genitalia). S0 - None (absent) S1 - Mild (Occasionally Present but does not disturb day to day activities) S2 - Moderate (Present and disturbs day to day activities) S3 - Severe (Patient rolls over bed due to pain)
Saraktamutrata (Hematuria)   Sm0 - None (absence of RBC in urine) Sm1 - Mild (3-5 RBC in urine) Sm2 - Moderate (presence of 10-20 RBC in urine) Sm3 - Severe (presence of more than 20 RBC in urine)
Mutrakruchrata   Mk0 - None (Absence of symptom) Mk1 - Mild (Occasional pain during micturition) Mk2 - Moderate (Tolerable pain at starting and during micturition) Mk3 - Severe (Intolerable pain at starting and during micturition and prolonged after micturition)
Mutradaha (Burning micturition)   Md0 - None (Absence of burning sensation) Md1 - Mild (Rare burning in the morning or at starting micturition) Md2 - Moderate (Tolerable burning in the morning and at starting Md3 - Severe (Intolerable burning in the morning at the starting of micturition and prolonged after micturition)

Assessment of overall effect of therapy

Complete Remission Absence of calculi in USG of KUB and 100% relief in Chief complaints.
Marked improvement Reduction in size of stone with more than 75% and less than 100% improvement in chief complaints was recorded as marked improvement.
Moderate improvement Reduction in size of stone with 75% to 50% improvement in chief complaints was recorded as moderate improvement.
No improvement No Reduction in size of stone and less than 25% improvement in chief complaints was recorded as no improvement.

The Results were analyzed statistically by using, Chi square test, Paired sample “t” test, individual sample “t” test and Mann whitney U test as inferential statistics and mean, standard deviation, frequency, percentage as Descriptive statistics using SPSS for windows software.

Observations

In the present study it was observed that Mutrashmari was common in the age group of 30-50 years (55.6%), males (60%) were more affected than females (40%), it was mostly observed in employees (26.7%) and homemakers (24.4%) followed by farmers (17.8%) and


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Hebballi P et al: Kulatthadi Ghrita management of Mutrashmari vis-à-vis Urolithiasis

labors (17.8%), incidence was more in lower middleclass population (82.20%) and was more in people with irregular dietary habits.

Pain (57.8%) was the most predominant symptom observed in the study and other symptoms such as Mutrakrichra (4.4%), Mutradaha (2.2%), Saraktamutrata (15.6%) were observed in very less proportion of the study population.

In the present study, majority of subjects had calculi ranging between 4-6mm in diameter and multiple in number.

Results

18 subjects in Group A and 18 subjects in Group B were presented with different grades of pain where both the groups showed highly significant result on pain relief with P value 0.000.

Table 3: Showing results on pain in Group A and Group B

Groups   Shoola (pain) X2 value P value P value between the groups
BT AT
Group A Nil 2 20 32.727 0.000 0.317
Mild 9 0
Moderate 6 0
Severe 3 0
Total 20 20
Group B Nil 3 19 26.436 0.000
Mild 4 1
Moderate 12 0
Severe 1 0
Total 20 20

In Group A, 2 subjects had Mutradaha where as in group B, 1 subject was presented with Mutradaha and the results were non-significant in both the groups with the P value o.487 and 1.000 respectively.

Table 4: Showing results on Mutradaha Group A and Group B

Groups Mutradaha X2 value P value P value between groups
BT AT
Group A Nil 18 20 2.105 0.487 1.000
Mild 2 0
Total 20 20
Group B Nil 19 20 1.026 1.000
Mild 1 0
Total 20 20

3 subjects in Group A presented with the symptom Saraktamutrata which was mild, the result was clinically significant but statistically nonsignificant.

No subject in Group B presented with Saraktamutrata.

Table 5: Showing results on Saraktamutrata Group A and Group B

Groups Saraktamutrata X2 value P value P value between groups
BT AT
Group A Nil 17 20 3.243 0.072 1.000
Mild 3 0
Total 20 20
Group B Nil 20 20 - 0.231
Total 20 20

2 subjects in Group A and 1 subject in Group B were presented with mild degree of Mutrakrichra, the results were statistically non-significant with the P value 0.349 and 1.206 respectively.

Table 6: Showing results on Mutrakrichra Group A and Group B

Groups Mutrakrichra X2 value P value P value between groups
BT AT
Group A  Nil 18 20 2.105 .349 1.000
Mild 1 0
Moderate 1 0
Total 20 20
Group B Nil 19 20 1.206 1.000
Mild 1 0
Total 20 20

Result on objective parameters

Number of calculi

Among 20 subjects in Group A, 12 had solitary kidney stone and 8 had multiple stones. After the completion of intervention, in 13 subjects’ calculi were expelled and 7 subjects had single calculus at different locations of urinary system. Where as in group B 10 subjects had single stone and 10 had multiple calculi. After intervention, 15 subjects had no calculi and 5 had single stone.

In Group A the mean value of number of stones was 1.65 before intervention and 0.35 after intervention where as in Group B Mean value was 2.15 before intervention and 0.25 after intervention.

Both the groups were statistically highly significant with P value 0.000.


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Hebballi P et al: Kulatthadi Ghrita management of Mutrashmari vis-à-vis Urolithiasis

Illustration 1: Result on number of stones (Group A)
jaims_2073_01.JPG

Illustration 2: Result on number of stones (Group B)
jaims_2073_02.JPG

Size of Stone: In Group A before intervention 11 subjects had calculi measuring 4-6mm and 9 had calculi measuring 6-8mm. After intervention, there were 4 subjects with calculi measuring 4-6mm and 2 subjects had calculi of 6-8mm. The mean value was 2.45 which changed to 0.70 after intervention. In Group B 16 subjects had calculi measuring 4-6mm and 4 had calculi measuring 6- 8mm before intervention. After intervention 15 subjects had no calculi, 1 was found to have calculus of 4mm size and 4 of them had calculi measuring 6-8 mm. The mean value was 2.20 before intervention which changed into 0.45 after intervention. Both the groups were statistically highly significant with P value 0.000.

Illustration 3: Result on size of stones (Group A)jaims_2073_03.JPG


Illustration 4: Result on size of stones (Group B)
jaims_2073_04.JPG

Site of stones: In 13 subjects of Group A the location of Stone was kidney, in 6 the location was ureter and 1 subject had stone in both kidney and ureter before intervention. Among them 13 subjects had no calculi after intervention and 7 had stones in kidney. The mean value of site of stones was 1.40 before intervention that changed to 0.35 after intervention. In Group B, 15 subjects had stone in kidney, 3 had in ureter and 2 had in both kidney and ureter before intervention. Among them 15 had no calculi after intervention and 5 had stone in kidney. The mean value was 1.35 before intervention and 0.25 after intervention. Both the groups were statistically highly significant with P value 0.000

Illustration 5: Result on the site of stones (Group A)
jaims_2073_05.JPG

Illustration 6: Result on the site of stones (Group B)
jaims_2073_06.JPG



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Hebballi P et al: Kulatthadi Ghrita management of Mutrashmari vis-à-vis Urolithiasis

Discussion

Probable mode of action of drugs:

Table 7: Showing ingredients of the formulations

Kulatthadi Ghrita Kulattha, Saindhava Lavana, Vidanga, Sharkara, Padmaka, Yavakshara, Kushmanda Beeja, Gokshura Beeja, Varuna Kwatha, Goghrita.
Nagaradi Kashaya Shunthi, Varuna Twak, Gokshura, Pashanabheda, Bramhi
Badarashma Pishti -

Kulatthadi Ghrita is Madhura, Tikta, Kashaya Rasa Pradhana which possess Laghu, Snigdha Guna, Ushna Veerya, Madhura Vipaka and Tridoshahara. It aids, Ashmari Bhedana, Mutrasanjanana, Basti Shodhana activity. As the formulation is in the form of Ghrita it is inferred to reduce Rukshata of aggregated particles there by produce smoothness to stone which enhances Ashmari Bhedana Karma of the drugs such as Varuna, Yavakshara and Kulattha helps in disintegration and dissolution of the calculi. Mutrala property of the drugs such as Gokshura, Kushmada, Vidanga, Padmaka will help in flushing out the disintegrated calculi. Further Deepana, Basti Samshodhana properties of Kushmada and Gokshura prevents formation of stones and thereby reduces the chance of recurrence. Badarashma Pishti, another formulation in the intervention is fossilized tasteless stone. Studies indicated that Lapis judalicus powder can reduce the size of calcium oxalate stones due to presence of magnesium, which is a protective agent in calcium oxalate crystal growth. Moreover, its basic pH nature could be another inhibitor for stone production. Furthermore, SiO2 can change calcium oxalate monohydrate to calcium oxalate dehydrate which is more soluble.

Nagaradi Kashaya has Kashaya, Tikta Rasa, Katu Vipka and Ushna Veerya. Ingredients of Nagaradi Kashaya such as Shunthi, Yavakshara and Bramhi have Shulahara property, which helps in reducing Shoola in Ashmari. Varuna, Pashanabheda and Yavakshara have Ashmari Bhedana activity there by help in disintegration of calculi. Gokshura with its Mutrala property helps in expulsion of calculi. In addition to this it has Kaphavatahara action. Thus, with Ashmaribhedana, Mutrala and Shulahara properties, Nagaradi Kashaya acts against Mutrashmari by virtue of its Dosha Pratyaneeka and Vyadhi Pratyaneeka property.

Conclusion

In the present study, results obtained between the groups is non-significant. In spite of having almost similar results, Group A showed complete remission in 13 subjects and marked improvement in 7 of them whereas Group B showed complete remission in 15 subjects and marked improvement in 5 subjects. From the above data it can be concluded that, both the groups are equally effective in reducing the size of stones and relieving the symptoms. Till date there is no recurrence of Mutrashmari or symptoms of Mutrashmari are observed in the subjects involved in the study. With the obtained result it can be concluded that Kulatthadi Ghrita in combination with Nagaradi Kashaya and Badarashma Pishti can be administered safely and effectively in the management of Mutrashmari.

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