E-ISSN:2456-3110

Research Article

Vatashteela

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 10 November
Publisherwww.maharshicharaka.in

A controlled clinical trial to evaluate the efficacy of Tilanala Kshara in the management of Vatashteela vis-a-vis Benign Prostatic Hyperplasia

Ravi P R.1*, Rajendra V.2
DOI: http://dx.doi.org/10.21760/jaims.7.10.16

1* Rahul Ravi P, Final Year PG Scholar, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India.

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

Background: Benign prostatic hyperplasia is the most common urological disease among elderly men, which is characterized by hypertrophic nodular changes of the prostate gland, which is located at the base of the bladder surrounding the proximal urethra. Gland grows at the rate of 2.4cm3/year after the age of 40 owing to the change in hormonal environment. In India, the prevalence rate is around 50% in men above the age of 65 years. The condition can be corelated to Vatashteela in Ayurveda based on the symptomatology. Objective of the study: To evaluate the efficacy of Tila Nala Kshara in the management of Muthraghata vis-a-vis BPH. Materials and Methods: A double arm open labelled clinical study with pre-post-test design was carried out at Government Ayurveda Medical College and Hospital, Mysuru. Data was collected as per the proforma prepared for the purpose of the study. Tila Nala Kshara was administered as intervention in 54 subjects and the control drug was Gokshuradi Guggulu. The data was analysed using SPSS descriptive and inferential statistics. Results: Among the objective parameters, change in prostate volume was significant between the groups with a P value 0.024. But for postvoid residual volume, the difference between the groups was not statistically significant. For subjective parameters which includes IPSS total and Quality of life scale, the difference between the groups was statistically nonsignificant. Conclusion: Tilanala Kshara when used along with Gokshuradi Guggulu was observed to improve general condition of the subjects to greater extent, which clearly implies the added effect of the trial drug.

Keywords: Vatashteela, BPH, Prostate, Tilanala Kshara

Corresponding Author How to Cite this Article To Browse
Rahul Ravi P, Final Year PG Scholar, Department of PG Studies in Kayachikitsa, Government Ayurveda Medical College, Mysuru, Karnataka, India.
Email: 		Rahul Ravi P, V. Rajendra, A controlled clinical trial to evaluate the efficacy of Tilanala Kshara in the management of Vatashteela vis-a-vis Benign Prostatic Hyperplasia. J Ayu Int Med Sci. 2022;7(10):127-132.
Available From
https://www.jaims.in/jaims/article/view/2126

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2022-09-24 2022-09-26 2022-10-03 2022-10-10 2022-10-17
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
Nil Nil Yes 16%

© 2022by Rahul Ravi P, V. Rajendraand 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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Introduction

Mutraghata comprises of a group of disorders related to Basti and Mutravaha Srotas. Mutraghata denotes a condition in which there is Vibandha in Mutravaha Srotas resulting in retention of urine.[1]

Benign Prostatic Hyperplasia, which is generally abbreviated as BPH, is a disease, which is particularly seen in elderly men. It is considered as one of the major causes of lower urinary tract symptoms and bladder outflow obstruction. Among the varieties of Mutraghata, mainly Vatashteela resembles the condition of BPH. Histologically distinguishable BPH will be present in 8% of men aged 31-40 and progressively increases markedly with age to about 80% by the ninth decade of life. In India, the prevalence rate is around 50% in men above the age of 65 years.[2]

Although BPH is not a life-threatening condition, its impact on life can be significant, as it is the commonest cause for significant lower urinary tract symptoms (urgency, frequency, nocturia, incomplete evacuation of urine and weakness of urine stream) and bladder outflow obstruction in men.[3]

In last three decades, despite of the intense research efforts to elucidate the underlying aetiology of prostatic growth in older men, the exact “cause and effect” relationship has not been established. Considering the limitations of the contemporary line of management, the present study was performed to evaluate the efficacy of Tilanala Kshara in the management of Vatashteela vis-à-vis BPH. Kshara is one among the treatment modalities mentioned in Ayurvedic Samhita for all types of Muthraghata.[4]

Tila Nala Kshara[5] is the trial drug selected for the study along with Gokshuradi Guggulu[6] as the control drug. The drugs selected are indicated for Mutravaha Sroto Vikara including all varieties of Muthraghata. Hence the present study "The controlled clinical trial to evaluate the efficacy of Tilanala Kshara in Vatashteela vis-a-vis BPH” was carried out.

Objective of the Study

To evaluate the efficacy of Tila Nala Kshara in the management of Muthraghata vis-a-vis BPH.

Materials and Methods

The materials used in the study were Tila Nala Kshara and Gokshuradi Guggulu.

Source of drug and method of preparation

Tila Nala for the preparation of Tilanala Kshara was procured from farmers of native Bannur district of Karnataka. Tila was dried and burnt at the native place itself and ash was collected. The preparation process was carried out at the inhouse pharmacy of GAMC and Hospital Mysuru.

Gokshuradi Guggulu Manufactured by GMP certified unit of Punarvasu Ltd. Nadiad, Gujarat and was procured from local vendors of Mysore.

Method of collection of data

Study design: Double arm open labelled control clinical trial with pre and post study design.

Sample size: Study comprised of 59 registered subjects (30 in trial group and 29 in control group) out of which 5 were drop outs. The study was completed on 54 subjects with 28 in trial group and 26 in control group.

Duration of intervention: 30 days

Inclusion criteria

1. Male Subjects belonging to age group of 40 to 70.

2. USG of bladder suggestive of residual urine volume up to 100ml.

3. Mild to moderate grades of BPH with prostate weight up to 75 gm

4. Both fresh and treated cases of Vatashteela vis-à-vis BPH

(Fresh cases included freshly detected and untreated cases of Vatashteela vis-à-vis BPH and treated cases included already diagnosed as Vatashteela vis-à-vis BPH, who had voluntarily discontinued the earlier treatment and were included with a flush out period of 7 days)

Exclusion criteria

1. Subjects with congenital hypothyroidism, chronic history of hypothyroidism (>5 yrs.) and secondary 1. Subjects suffering from malignancy, congenital deformities of urogenital tract or any other pelvic pathologies


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2. Chronic UTI, urinary calculus, renal failure, urinary stricture

3. Systemic diseases like uncontrolled Diabetes mellitus (RBS range above 300mg/dl), Hypertension (stage 3 or above), Tuberculosis, hemiplegia, parkinsonism, and other disorders that may interfere with the present

4. intervention

5. Subjects with immune compromised conditions such as HIV

6. Subjects with USG findings suggestive of Hydroureteronephrosis

7. Subjects unfit for Paneeya Kshara intake such as acid peptic disorders

Diagnostic criteria: USG abdomen & pelvis and digital rectal examination

  • International prostate symptom score (IPSS)
  • Scoring for prostate weight, Post void residual volume, size of prostate on DRE

Assessment Criteria
Primary assessment parameters

1. Assessment using IPSS was done.

IPSS assessment includes

  • Incomplete emptying
  • Frequency
  • Intermittency
  • Urgency
  • Weak stream
  • Straining
  • Nocturia

2. Ultrasonography of abdomen and pelvis

Following parameters were assessed

  • Prostate weight
  • Prostate size
  • Post void residual urine volume

Secondary assessment parameters

1. Basti Shola

2. Mootra Rodha

3. Ghana Granthi

4. Basti Admaana

Table 2: Shows the International prostate scoring scale.

International Prostate Symptom Score (IPSS) /American Urological Association Symptom Index (AUA-SI)

In the past one month Not at all Less than 1in 5 times Less than half the time About half the time More than half the time Almost always Your score
Incomplete emptying 0 1 2 3 4 5  
Frequency 0 1 2 3 4 5  
Intermittency 0 1 2 3 4 5  
Urgency 0 1 2 3 4 5  
Weak stream 0 1 2 3 4 5  
Straining 0 1 2 3 4 5  
  None Once Twice Thrice Four times Five or more  
Nocturia 0 1 2 3 4 5  
Total IPS score              

Score: 1-7: Mild 8-19: Moderate 30-35 : Severe

Quality of life due to urinary symptoms Delighted Pleased Mostly satisfied Mixed Mostly dissatisfied Unhappy Terrible
Score 0 1 2 3 4 5 6

Assessment schedule

Assessments were carried out 3 times during the course of intervention

Assessment using IPSS was done on (0th) day, (15th) day and on (30th) day of intervention.

Ultrasonography of abdomen and pelvis was done before the beginning of intervention and after the completion of intervention.

Statistical methods: The results were analysed statistically by using the following statistical methods:

Descriptive statistics: Mean, Standard deviation, Frequency, Percentage

Inferential testing -

  • Chi-square test, Wilcoxon signed rank test
  • Repeated measures ANOVA, Mann Whitney U test
  • Paired sample and individual sample “T” test

All the statistical methods were done using SPSS for windows

Intervention: Total duration of the intervention was 30 days. Intervention included,


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Group A: 1gm of Tilanala Kshara in 2 equally divided doses after food with lukewarm water as Anupana and Gokshuradi Guggulu 3 gm in 3 equally divided doses after food with lukewarm water as Anupana were administered for 30 consecutive days.

Group B: Gokshuradi Guggulu 3 gm in 3 equally divided doses after food with lukewarm water as Anupana for 30 consecutive days was administered.

Observations

Age: 45 subjects were belonging to 61-70 years age group, 9 in 51-60 years and 5 were from 41-50 age group.

Occupation: 16 subjects were farmers, 12 subjects were engaged in bussiness, 11 were unemployed, 3 daily wagers and remaining 17 were having other occupations.

Fresh and treated cases

39 fresh cases 20 treated cases were included.

Diet: 45 subjects were having mixed diet and remaining 14 were vegetarians.

Prostate size: Grade 1 enlargement was found in 50 subjects and grade 2 enlargement was seen in 9 subjects.

Residual volume: 23 subjects did not have any residual urine, 16 subjects had grade 1 PVRU and grade 2-4 grade 3-16

Enlargement of lobe

It was noted that the median and lateral lobes enlargement is the most common presentation.

Observations on clinical features of BPH

Among the symptoms of BPH, increased frequency of micturition was observed in 56 subjects, nocturia was seen in 44, weak stream in 37, urgency in 31 subjects, incomplete evacuation of urine in 22 and intermittency in 15 subjects.

Results

A total of 59 subjects were registered for the study, there were 5 dropouts.

The results were obtained by assessing 54 subjects who have completed the study.


Result on prostate volume

A statistically highly significant change in Prostate volume was obtained in both the groups with P value <0.001 in both the groups. The mean volume of prostate was 45.29 and after intervention it came to 38.07 in trial group. The mean in control group was 33.81 and after intervention it was 31.19. The change in prostate volume between the two groups is statistically significant with a P value 0.024 with trial group having better result.

Result on Post void residual urine volume

A statistically significant change in Post residual urine volume was obtained in both the groups with a P value 0.022 in Trial group and 0.006 in Control group. Mean value was 33.75 in trial group before intervention and it came to 19.54 after intervention. A mean of 19.82 was observed before intervention in control group which came down to 13.54. The change in post void residual volume between the groups did not show any statistically significant difference with P value 0.421.

Result on IPSS total score
A statistically highly significant result in IPSS score was noticed in both the groups with P value<0.001 in Trial group and 0.002 in Control group. The change in IPSS score after the course of intervention was not statistically significant between the groups with a P value 0.541.

Result on Quality-of-life scale of IPSS
A statistically highly significant change in Quality of Life was obtained in both the groups with a P value <0.001. The change in quality of life after the course of intervention was not statistically significant between the groups with a P value 0.244.

Result on IPSS parameters
Among the sub parameters of IPSS, significant change between the groups were observed in urgency and nocturia. Frequency, intermittency, burning micturition, weak stream and straining didn’t showed statistically significant difference between the groups.

Table 4: Showing results of overall assessment between the groups

Parameter Prostate volume Post void residual volume IPSS total IPSS QOL
Groups Trial Control Trial Control Trial Control Trial Control
Pre -Mean 45.29 33.81 33.75 19.82 2.79 2.35 3.54 3.08
Post-Mean 38.07 31.19 19.54 13.54 2.04 1.92 2.57 2.04

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Discussion

Probable mode of action of Tilanala Kshara

Tila was the selected drug for Kshara preparation considering its Vata Kaphahara property which adds on to the property of Kshara. It is Alpa Mootrakrit and Grahi.[7]

In BPH, where the major symptoms are increased frequency, urgency and nocturia these properties of Tila can come useful. The Grahi action of a drug usually can be assessed by the potency of the particular drug to increase the contractile tone of sphincter. This can be considered also for sphincters related to Basti. Along with Vatagna action, Tila is also Balya and Agnideepana. The Balya action could give strength to bladder muscles like detrusor which can improve symptoms like incomplete evacuation and urgency. The Samprapthi starts from ama formation and Agnidushti, hence the selected drug preferably should have Agni Deepana action also. Snigda Ushna Guna and Ushna Veerya also helps in Vatanulomana which enhances the overall effect of the intervention. Moreover, the antioxidant action of Tila also helps in free radical scavenging and there by protects the prostate tissue from damage.

Probable reasons for reduction in PVRU

In mean PVRU scores a significant decrease was observed after intervention in both the groups. When group-wise decrease was verified, a non-significant difference was observed between the groups. Drugs in Gokshuradi Guggulu might have produced strength to detrusor muscle to do sufficient contraction and Kshara helps for easy flow of urine out by keeping the bladder neck and prostatic urethra open. Even Mutrala and Shothahara Karma of the drugs might have acted to get the result.

Probable reasons for reduction in Prostate size

Even though both groups showed significant results, it was observed that Trial group had a better result in reducing the size of prostate. It could be because of the added Lekhana property from Kshara. It is also noted that few patients had also recorded an increase in the size of prostate. This could be due to the natural progressive course of the disease. The size either progresses gradually over a period of time or stays dormant for years.


Conclusion

Benign Prostatic Hypertrophy is having a wide spectrum of symptomatology. Even though it is very difficult to restrict and fit it into any single disease pathology as per Ayurvedic literature, in the present study BPH is considered as Vatashteela after analysing the Vyutptti of the term Vatashteela, Nidana, Samprapti and Lakshana of the disease Vatashteela. BPH is a Vyadhi of Vridhavastha where in Vata will be naturally in a predominant condition,[8] and the disease is more prevalent after the 6th decade, the age group in which Shodhana therapy is contraindicated. Hence Shamana Oushadhi have been selected for the controlled study. The Ayurvedic theory proposes predominance of Vata as age progresses and with increased Rukshaguna the manifestation of Vatashteela could be more. From the obtained data, it can be inferred that the size of prostate gland is not directly proportional with the intensity of symptoms including the post void residual volume of urine. But the severity of embarrassing symptoms was more in subjects with median lobe enlargement of prostate. Both groups showed significant results in both objective as well as subjective criteria. There was no statistically significant difference in results between the groups, but after looking at the mean differences of the objective parameters before and after the clinical trial, it can be inferred that the trial group had comparatively better outcome in majority of the parameters including size of the prostate, urgency and nocturia.

Reference

1. Sushruta, Sushrutha Samhitha, with Dalhana’s Nibandha Sangraha commentary, edited by Vaidya Yadavji Trikamji and Narayana Ramacharya, Choukhamba Krishnadas Acadamy Varanasi, 2004. Su. ut -58/27 p789

2. R.P.Mathur et al, Role of alpha blockers in hypertension with BPH,2014, Journal of The association of Physicians of India, Reapraisal of alpha blockers in hypertension, Vol.62,Page no.40-44

3. Norman.S.Williams, P.Ronan O.Connell, Andrew.W.Mccaskie , Bailey and love’s, short practice of surgery, 27th Edition 2018, chapmann and Hall, ELBS London, Page no.1458


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4. Acharya JT, editor, 2005, Nibandhasangraha Commentary of Sri Dalhanacharya on Sushrutha Samhita of Sushrutha, Uthara Tandra; Muthraghata Pratishedha: chapter 58, verse 27. Varanasi: Chaukhambha Orientalia Publisher, 2005, p789

5. Shastri.B.S, editor, 1973, Vidyotini Hindi commentary by Vaidya Lakshmipathi sastri on Yogaratnakara Utharardha, Ashmari chikitsa, Samanya vidhi, Kshara prayoga, verse -1, Varanasi: Chaukhamba Sanskrit Sansthan ,1973,p73

6. Vidyasagar.P.S, editor, 2013, Adhamalla’s Dipika & Kashirama’s Gudhartha Dipika commentaries on Sharangadhara Samhita of Acharya Sharangadara -Madyamakhanda, chapter 7: Gugguluvidhanam, verse 84-87, Varanasi: Chaukhamba Sanskrit Sansthan, 2013, p.204,205

7. K.Rajesh, V.Anurag Krishna Tila: A Rasayana Dravya, The pharma innovation Journal

8. Agnivesha, Charaka Samhita with Chakrapani’s Ayurveda Deepika Commentary, edited by Vaidya Yadavji Trikamji, Chaukhambha Krishnadas Acadamy, Varanasi, 2006 Vi. 8/122p 280


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