E-ISSN:2456-3110

Research Article

Erectile Dysfunction

Journal of Ayurveda and Integrated Medical Sciences

2022 Volume 7 Number 10 November
Publisherwww.maharshicharaka.in

An open label single arm clinical study on the effectiveness of Akarakarabha Vati in the management of Klaibya (Erectile Dysfunction)

Sabasannavar Jinnappa S.1*, Girish K.2, Srinivasan N.3, Sudhakar Powar V.4
DOI: http://dx.doi.org/10.21760/jaims.7.10.4

1* Sunil Sabasannavar Jinnappa, Final Year Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

2 KJ Girish, Professor, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

3 Nehaa Srinivasan, Final Year Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

4 Vibhu Sudhakar Powar, Assistant Professor, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.

Background: Klaibya (Erectile Dysfunction) is one of the common sexual disorders that affects physical and psychosocial health and may significantly impact the quality of life of sufferers and their partners. Sexual health and function are important determinants of quality of life. Although lifestyle modifications and psychotherapy are considered as the first-line of treatment in Erectile Dysfunction (ED), men presenting with such complaints expect the Ayurveda physician to help them with measures and medication that can have an improved result. Akarakarabaha is a potent drug mentioned in classical textbooks which is having the Shukrasthambaka (inhibition if delayed ejaculation), Balya (strength promoting activity), Vrishya (aphrodisiac), Vajikara properties and it’s having pharmacological activities like antioxidants, aphrodisiac, immunomodulatory effect, antidepressant, anti-diabetic, and effect on testosterone. Methods: Among 11 subjects, 10 of them completed the course of treatment. They were administered with Akarakarabha Vati 500 mg twice a day with milk as Anupana after food for 30 days and 15 days after cessation of medicine. For statistical analysis subjective parameters were assessed with Cochran Q test followed by McNemar test also Friedman's test followed by Wilcoxon sign rank test, and objective parameters were assessed by repeated measure ANOVA followed by Paired t-test. Results: There was statistically significant improvement in the Klaibya Samanya Lakshana and IIEF (International Index of Erectile function) score. Conclusion: Akarakarabaha Vati is effective in the management of Klaibya (Erectile Dysfunction).

Keywords: Ayurveda, Klaibya, Erectile dysfunction, Akarakarabaha, Vajikarana

Corresponding Author How to Cite this Article To Browse
Sunil Sabasannavar Jinnappa, Final Year Post Graduate Scholar, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka, India.
Email:
Sunil Sabasannavar Jinnappa, KJ Girish, Nehaa Srinivasan, Vibhu Sudhakar Powar, An open label single arm clinical study on the effectiveness of Akarakarabha Vati in the management of Klaibya (Erectile Dysfunction). J Ayu Int Med Sci. 2022;7(10):19-28.
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https://www.jaims.in/jaims/article/view/2117

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 19%

© 2022by Sunil Sabasannavar Jinnappa, KJ Girish, Nehaa Srinivasan, Vibhu Sudhakar Powarand 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].

Introduction

Vajikarana is a branch of Ashtanga Ayurveda that deals with reproduction, potency, and healthy offspring. In this discipline, infertility and sexual dysfunctions are diagnosed and treated in depth. Klaibya is a condition where even the man desires sexual intercourse and the partner is cooperative, he cannot perform the sexual act because of the absence of erection due to loss of rigidity. Erectile dysfunction (ED) is a common medical problem affecting approximately 15% of men each year and it’s estimated to affect more than 150 million men. Its incidence has been projected to increase significantly to over 320 million by the year 2025.[1] It is widely noticed in society, owing to a less generally reported sense of inadequacy. According to a survey conducted by the Massachusetts Male Aging Study (MMAS), 52 percent of males between the ages of 40 and 70 had some form of erectile dysfunction.[2] Sexual well-being is a crucial aspect of overall health. The couple's sexual concord conceals the couple's attainment of conjugal existence. In order to keep marital peace and happiness, healthy sexual functioning is essential. Sexual dysfunction has an impact on couple’s psychology, conduct, and relationships, which in turn impacts the quality and harmony of marital life, affecting the family and society. In the long run, it could lead to a variety of psychosomatic diseases in both couples. It gives a medium for expressing love, which serves as the foundation for all kinds of creative endeavours. The lack of which stifles the marital connection, leading to dissatisfaction and, in some cases divorce, as well as inefficiencies in executing ordinary tasks. Male Sexual Dysfunction encompasses coital performance and sexual intercourse issues in men. The achievement of a proper erection with sufficient stiffness for penetrative intercourse is the most important phase of sexual response, and its absence leads to failure and disappointment.

In Ayurveda, Klaibya is a condition where even the man desires sexual intercourse and the partner is cooperative, he cannot perform the sexual act because of the absence of erection due to loss of rigidity and even if a man attempts sexual act he exhibits breathlessness and perspiration. It is including of Bahudoshavastha (multifactorial vitiation of ailments) and Shukrakshaya (Hypospermia) as a whole, in specific Mano Dosha

(containments of mind) and Shukravaha Sroto (seminal pathway) Dusti.

Despite the fact that lifestyle changes and patient education[3] are the first-line treatments for erectile dysfunction (ED), men who present with such symptoms expect the physician to help them with medications that can have improved results. Better ED therapies are thus constantly a prime research priority. Here we have intended to assess the effectiveness of Akarakarabaha Vati in the management of Klaibya (Erectile Dysfunction). To fulfil this aim we have selected this study.

Materials and Methods

Method of collection of data

11 Patient were screened and selected based on the Klaibya Samanaya Lakshana[4] and based on IIEF score with specified inclusion like, Subjects with Minimum 3 months history of erectile dysfunction, aged between 25 to 60 years having Fairly good glycemic condition (DMT2) and exclusion criteria like, K/C/O essential hypertension and cardiac, hepatic, renal disorders, significant anatomical penile deformity, and history of prostatectomy or penile implant.

Table 1: Demographic and observational data in 11 Klaibya subjects on the bases of Samanya Lakshana.

Lakshana Present Absent
Linga Shaitily 11(100%) 0
Mogha Sankalpa Chesta 11(100%) 0
Mlana Shishnata 11(100%) 0
Swasartha               5(45.5%) 6(54.5%)
Swinna Gatrata 8(72.7%) 3(27.3%)

International index of erectile function (IIEF) contains 15 questionnaire which are about the effects the individual erection problems have had on their sex life over the last four weeks.

Categorised under 5 main domain. Sexual activity includes intercourse, caressing, foreplay & masturbation, sexual intercourse is defined as sexual penetration of your partner, sexual stimulation includes situation such as foreplay, erotic pictures etc., ejaculation is the ejection of semen from the penis (or the feeling of this), orgasm is the fulfilment or climax following sexual stimulation or intercourse.



Table 2. Demographic and observational data in 11 Klaibya subjects based on IIEF.

Q1. How often were you able to get erection during sexual activity?
Score Erectile function Frequency Percentage
0 No sexual activity 0 0
1 Almost never or never 2 18.2
2 A few times (less than half time) 8 72.7
3 Sometimes (about half the time) 0 0
4 Most times (more than half the time) 1 9.1
5 Almost always 0 0
Q2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration?
Score Erectile function Frequency Percentage
0 No sexual activity 0 0
1 Almost never or never 1 9.1
2 A few times (less than half time) 8 72.7
3 Sometimes (about half the time) 2 18.2
4 Most times (more than half the time) 0 0
5 Almost always 0 0
Q3. When you attempted intercourse, how often were you able to penetrate (enter) your partner?
Score Erectile function Frequency Percentage
0 Did not attempt intercourse 0 0
1 Almost never or never 6 54.5
2 A few times (less than half time) 4 36.4
3 Sometimes (about half the time) 1 9.1
4 Most times (more than half the time) 0 0
5 Almost always 0 0
Q4. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?
Score Erectile function Frequency Percentage
0 Did not attempt intercourse 0 0
1 Almost never or never 8 72.7
2 A few times (less than half time) 3 27.3
3 Sometimes (about half the time) 0 0
4 Most times (more than half the time) 0 0
5 Almost always 0 0
Q5. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
Score Erectile function Frequency Percentage
0 Did not attempt intercourse 0 0
1 Extremely difficult 7 63.6
2 Very difficult 3 27.3
3 Difficult 1 9.1
4 Slightly difficult 0 0
5 Not difficult 0 0
Q15. How do you rate your confidence that you could get and keep an erection?
Score Erectile function Frequency Percentage
1 Very low 0 0
2 Low 11 100.0
3 Moderate 0 0
4 High 0 0
5 Very high 0 0
Q9. When you had sexual stimulation or intercourse, how often did you ejaculate?
Score Orgasmic function Frequency Percentage
0 No sexual stimulation or intercourse 0 0
1 Almost never or never 0 0
2 A few times 0 0
3 Sometimes (about half the time) 8 72.7
4 Most times (more than half the time) 1 9.1
5 Almost always 2 18.2
Q10. When you had sexual stimulation or intercourse, how often did you have the feeling of orgasm or climax?
Score Orgasmic function Frequency Percentage
1 Almost never or never 0 0
2 A few times 0 0
3 Sometimes 7 63.6
4 Most times 2 18.2
5 Almost always 2 18.2
Q11. How often have you felt sexual desire?
Score Sexual Desire Frequency Percentage
1 Almost never or never 0 0
2 A few times 0 0
3 Sometimes 3 27.3
4 Most times 7 63.6
5 Almost always 1 9.1
Q12 how would you rate your level of sexual desire?
Score sexual desire Frequency Percentage
1 Very low or none at all 0 0
2 Low 0 0
3 Moderate 3 27.3
4 High 8 72.7
5 Very high 0 0
Q6. How many times have you attempted sexual intercourse?
Score Intercourse satisfaction Frequency Percentage
0 No attempts 0 0
1 One to two attempts 4 36.4
2 Three to four attempts 5 45.5
3 Five to six attempts 1 9.1
4 Seven to ten attempts 1 9.1
5 Eleven or more attempts 0 0
Q7. When you attempted sexual intercourse, how often was it satisfactory for you?
Score Intercourse satisfaction Frequency Percentage
0 Did not attempt intercourse 0 0
1 Almost never or never 8 72.7
2 A few times (less than half time) 3 27.3
3 Sometimes 0 0

4 Most times 0 0
5 Almost always 0 0
Q8. How much have you enjoyed sexual intercourse?
Score Intercourse satisfaction Frequency Percentage
0 No intercourse 0 0
1 No enjoyment at all 7 63.6
2 Not very enjoyable 4 36.4
3 Fairly enjoyable 0 0
4 Highly enjoyable 0 0
5 Very highly enjoyable 0 0
Q13. How satisfied have you been with your overall sex life?
Score Overall satisfaction Frequency Percentage
1 Very dissatisfied 8 72.7
2 Moderately dissatisfied 3 27.3
3 Equally satisfied &dissatisfied 0 0
4 Moderately satisfied 0 0
5 Very satisfied 0 0
Q14. How satisfied have you been with your sexual relationship with your partner?
Score Overall satisfaction Frequency Percentage
1 Very dissatisfied 8 72.7
2 Moderately dissatisfied 1 9.1
3 Equally satisfied & dissatisfied 2 18.2
4 Moderately satisfied 0 0
5 Very satisfied 0 0

Table 3: Distribution of 11 subjects of Klaibya based on Performance Anxiety

Performance Anxiety Count %
Present 10 90.9
Absent 1 9.1

Observations and Results

Table 4: Effect of therapy on Erection.

Parameter N Mean Greenhouse - geisser Greenhouse - geisser Error df Remarks
df F value P value
Erection BT total score 10 10.100 1.362 40.980 <.05 12.258 S
Erection 15th day total score 14.800
Erection 30th day total score 17.800
Erection 45th day total score 16.300

 

(I) Erection (J) Erection Mean Difference (I-J) Std. Error Sig. 95% Confidence Interval for Difference Remarks
Lower Bound Upper Bound
1 2 -4.700 .472 <.0125 5.769 -3.630 S
2 3 -3.000 .258 <.0125 -3.584 -2.415 S
3 4 1.500 1.024 >.0125 -3.584 -2.415 NS

Table 5: Effect of therapy on Intercourse satisfaction.

Parameter N Mean Greenhouse - geisser Greenhouse - geisser Error df Remarks
df F value P value
Intercourse satisfaction BT total score 10 5.200 1.000 17.063 <.05 18.930 S
Intercourse satisfaction  15th day total score 7.200
Intercourse satisfaction  30th day total score 8.000
Intercourse satisfaction  45th day total score 6.600

 

(I) Intercourse Satisfaction (J) Intercourse Satisfaction Mean Difference (I-J) Std. Error Sig. 95% Confidence Interval for Difference Remarks
Lower Bound Upper Bound
1 2 -2.000 0.365 <.0125 -2.826 -1.173 S
2 3 -0.800 0.326 >.0125 -1.538 -0.061 NS
3 4 1.400 0.339 <.0125 0.6310 2.1689 S


Table 6: Effect of therapy on Sexual Desire.

Parameter N Mean Greenhouse - geisser Greenhouse - geisser Error df Remarks
df F value P value
Sexual desire BT total score 10 7.500 1.000 2.250 >.05 9.000 NS
Sexual desire 15th day total score 7.700
Sexual desire 30th day total score 7.700
Sexual desire 45th day total score 7.700


Table 7: Effect of therapy on Orgasmic Function.

Parameter N Mean Greenhouse – geisser Greenhouse – geisser Error df Remarks
df F value P value
Orgasmic function BT total score 10 6.900   1.000 2.250   >.05 9.000 NS
Orgasmic function 15th day total score 7.100
Orgasmic function 30th day total score 6.900
Orgasmic function 45th day total score 6.900




Table 8: Effect of therapy on Overall Satisfaction

(I) Overall Satisfaction (J) Overall Satisfaction Mean Difference (I-J) Std. Error Sig. 95% Confidence Interval for Difference Remarks
Lower Bound Upper Bound
1 2 -1.700 0.213 <.0125 -2.182 -1.217 S
2 3 -1.600 0.163 <.0125 -1.964 -1.230 S
3 4 -0.600 0.221 >.0125 -1.100 -0.998 NS

 

Parameter N Mean Greenhouse – geisser Greenhouse – geisser Error df Remarks
df F value P value
Overall satisfaction BT total score 10 2.500 2.137 105.0 <.05 19.236 S
Overall satisfaction 15th day total score 4.200
Overall satisfaction 30th day total score 5.800
Overall satisfaction 45th day total score 6.400

Table 9: Effect of therapy on Performance Anxiety

Performance Anxiety Present Absent N P Remarks
BT 10 0 10 <0.05 S
15th Day 2 8
30th Day 0 10
45th Day 0 10

Bar diagrams 1: Demographic and Observational data in 11 subjects.

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Bar diagrams 2: Effect of Therapy on IIEF Scale.

jaims_2117_02.JPG

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jaims_2117_06.JPG

Discussion

In the present study, 20 subjects were screened, 11 were registered of which 10 have completed the course of treatment. The subjects were asked for follow up on 15th day, 30th day and 45th day. Sexual parameters were assessed before treatment and during each follow up on the basis of International Index of Erectile function. The results obtained on various parameters were statistically analyzed and presented in the forms of Tables. For statistical analysis subjective parameters were assessed with Cochran Q test followed by McNemar test and objective parameters were assessed by Friedman's test followed by Wilcoxon sign rank test and Repeated Measure Anova followed by Paired t-test.

Probable effect of Akarakarabha Vati on Klaibya

Akarakarabha possesses the Vrishya, Shukrasthambaka, Balya, Vajikara properties as mentioned in Priya Nighantu[5] and Brihat Nighantu Ratnakara.[6] Akarakarabha (Anacyclus pyrenthrum) is most widely growing species of the family Asteraceae. The plant having several pharmacological actions such as aphrodisiac, antidiabetic, immunostimulant, inhibitory effects, antidepressant activity, anticonvulsant activity, memory-enhancing activity, antimicrobial activity, antioxidant, local anaesthetic effect, insecticidal effect, interactions with testosterone, interaction with libido, and its interaction with testicles.[7] Akarakarabha having Katu Rasa Pradhana and Teekshna Guna which may does Srotoshodhana and it may clear the Srotas which further increase the blood flow there by improves the erectile function.[8]

As Akarakarabha is having the properties like Balya and Vatahara, it may help in the Klaibya Lakshana like, Linga Shaitilya (flaccidity of penis)

and Mlanashishnata (loss of penile strength due to loss of rigidity) there by improves the Moghasankalpa Chesta (futile sexual act). It possesses Shukrasthambana property which helps in Shukragatavata and may help in the Klaibya.

Effect of Akarakarabha Vati on erectile function

There was a statistically significant change in the Erectile function and intercourse satisfaction from BT to 30th day (on intervention) and it shown non-significant after 45th day follow up without intervention. But overall significant improvement seen from BT to 45th day. As a result of Apana Vatadushti, the penis could become Shitila and Mlana, resulting in erectile dysfunction. Akarakarabhaha’s qualities such as Balya and Vatahara, it aids in the treatment of Klaibya Lakshanas such as Linga Shaitilya (penile laccidity) and Mlana Shishnata (penile stiffness loss) and so improves the Moghasankalpa Chesta (futile sexual act) there by it improves the erectile function. It has Shukra Sthambana, which helps with Shukragatavata and also aid with Klaibya. Akarakarabha contains Katu Rasa (pungent) and Teekshnaguna (penetrating properties), which may perform Sroto Shodhana (purification of channels), increasing blood flow and so improving erectile function.

As decreased antioxidant defenses is prevalent in ED and play major roles in reducing vascular nitrous oxide. Akarakarabha contains a natural source of antioxidants due to the presence of DPPH (di-phenyl pycrilhydrazyl-hydrate) in the drug which helps to generate NO in vascular level improve blood circulation. Thereby improves the erectile function.[9]

Effect of Akarakarabha Vati on sexual desire & orgasm

There was a statistically significant change in the Sexual desire and orgasm from BT to 30th day (on intervention) and it shown non-significant after 45th day follow up without intervention. Subjects were having proper Sexual desire and orgasmic function which further no change has been observed.

Effect of Akarakarabha Vati on intercourse satisfaction

There was a statistically significant change in the intercourse satisfaction from BT to 30th day (on intervention) and it shown non-significant after 45th


day follow-up without intervention. But overall significant improvement seen from BT to 45th day. The penis may become Shitila (flaccid) and Mlana (loss of rigidity) as a result of Apana Vatadushti, resulting in erectile dysfunction. Akarakarabha possesses traits like Balya and Vatahara, and it can help with Klaibya Lakshanas like Linga Shaitilya (penile laccidity) and Mlana Shishnata (penile stiffness loss), as well as improving the Moghasankalpa Chesta (futile sexual act) and so improving erectile function. Intercourse satisfaction will improve as erectile function improves.

Effect of Akarakarabha Vati on overall satisfaction

There was a statistically significant change in the Overall satisfaction from BT to 30th day (on intervention) and it shown non-significant after 45th day follow up without intervention. But overall significant improvement seen from BT to 45th day. The overall satisfaction will improve once the erectile function, intercourse satisfaction, and sexual desire have improved.

Conclusion

The fundamental prerequisite for a proper sexual intercourse with a willing partner is a proper erection. Any sexual dissatisfaction leads to a significant negative attitude among couples toward one another, resulting in major family issues. Sexual disorders are becoming one of the leading reasons of family conflict and divorce. Ayurvedic research is aiming for a comprehensive revalidation of current elements using modern methods. An in-depth analysis and cautious appraisal are required to achieve that objective. In this study, administration of Akarakarabaha Vati with milk as Anupana for the period of 30 days and 15 days after cessation of medicine had shown statistically significant improvement in the Klaibya Lakshana and in IIEF score on medication (i.e., BT- 30th Day).

There was no significant change observed on cessation of medicine (i.e., 30-45th Day). But overall, from BT to 45th day it was found to be significant. Hence Akarakarabha Vati of 500 mg twice a day after food with milk as Anupana for 30 days on intervention and after 15 days after cessation of intervention is effective in the management of Klaibya.


Reference

1. Abolfo touch MA, Al-Helali NS. Effect of erectile dysfunction on quality of life. Eastern Mediterranean Health Journal, 2001, 7(3):510–518.

2. Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: Results of the Massachusetts Male Aging Study. J Urol 1994; 151:54–61.

3. Kasper, Braunwald, Fauci, Hauser, Longo, Jameson. Harrison’s principlesof internal medicine. 16 th ed. CD ROM. New York: McGraw-Hill Medicalpublishing division; 2005. Page no.272-273

4. Vaidya Harishandra Sinha Kushavaha. Charaka Samhita volume 2. Varanasi; Chaukamba Orientalia; reprint- 2018 pg 822

5. P V Sharma, Priya Nighantu 2nd ed. 1995, 30/52, Pg. 84,Chaukhambha surabharati prakashan, Varanasi, Pages 275.

6. Golakvasi lala Shaligramaji VAishya, Brihat Nighantu Ratnakara 7-8th volume. ed.1997, pg.116-117, Khemaraj Shreekrishnadas Prakashan, Pages 935.

7. Khaleem Ahmad, Review on akarakarabha (Anacyclus pyrethrum); A unique single drug. The journal of pharmacology 2020;9(6):423-428

8. Vaidya Harishandra Sinha Kushavaha. Charaka Samhita volume 1. reprint- 2018, 26/43 pg.386 Varanasi; chaukamba orientalia; pg 962

9. Manouze H, Bouchatta O, Gadhi AC, Bennis M, Sokar Z, Ba-M’hamed S. Anti-inflammatory, Antinociceptive, and antioxidant activities of methanol and aqueous extracts of Anacyclus pyrethrum roots. Frontiers in pharmacology. 2017;8:598