Journal of Ayurveda and Integrated Medical Sciences

2025 Volume 10 Number 1 JANUARY
Publisherwww.maharshicharaka.in

An Open Label Single Arm Clinical Study on Gokshurakadi Churna in the management of Klaibya (Erectile Dysfunction)

Bhat AN1*, Jadhav LL2
DOI:10.21760/jaims.10.1.2

1* Anush N Bhat, Post Graduate Scholar, Dept of Kayachikitsa, Sri Dharmasthala Manjunatheshwar College of Ayurveda and Hospital, Hassan, Karnataka, India.

2 Lakshmiprasad L Jadhav, Professor, Dept of Kayachikitsa, Sri Dharmasthala Manjunatheshwar College of Ayurveda and Hospital, Hassan, Karnataka, India.

Background: Erectile dysfunction (ED) has been defined as the inability to achieve/ maintain penile erection which leads to unsatisfactory sexual intercourse. Its incidence increases drastically from about 6% in the age group 20-29 years, to 50-70% in the age group 40-79 years. Its incidence has been projected to increase significantly to over 320 million by the year 2025. Erectile dysfunction (ED) affects physical and psychosocial health and has a significant impact on the quality of life of sufferers and their partners and families. Thus, it can be considered that management of ED is of significant importance. Considering the above facts, the present clinical study on the effectiveness of Gokshurakadi Churna Granules in the management of Klaibya (Erectile Dysfunction) was undertaken.

Objectives: To study the effect of Gokshurakadi Churna Granules with milk in subjects diagnosed with Klaibya (Erectile dysfunction).

Methodology: Among the 22 registered patients, 20 of them completed the course of the treatment. They were administered with Gokshurakadi Churna Granules 6gms BD morning and night after food with milk for a period of 30 days. Subjective parameter was analysed using paired sample t test.

Result: There was statistically significant improvement in subjective parameter of Klaibya (Erectile Dysfunction) (P <0.05).

Conclusion: Gokshurakadi Churna Granules is effective in the management of Klaibya.

Keywords: Erectile Dysfunction, Klaibya, Gokshurakadi Churna Granules

Corresponding Author How to Cite this Article To Browse
Anush N Bhat, Post Graduate Scholar, Dept of Kayachikitsa, Sri Dharmasthala Manjunatheshwar College of Ayurveda and Hospital, Hassan, Karnataka, India.
Email:
Bhat AN, Jadhav LL, An Open Label Single Arm Clinical Study on Gokshurakadi Churna in the management of Klaibya (Erectile Dysfunction). J Ayu Int Med Sci. 2025;10(1):7-13.
Available From
https://jaims.in/jaims/article/view/3942

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2024-12-10 2024-12-20 2024-12-30 2025-01-11 2025-01-24
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 13.23

© 2025by Bhat AN, Jadhav LLand 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].

Download PDFBack To ArticleIntroductionMaterials and MethodsObservationsResultsDiscussionConclusionReferences

Introduction

Important pillars of healthy life are Ahara, Nidra and Abramcharya.[1] Sexual health and functions are important determinants of quality of life. Sexual disorders affect physical and psychosocial health and may have a significant impact on the quality of life of sufferers and their partners. Erectile dysfunction (ED) is a common medical problem affecting approximately 15% of men each year.[2]

Incidence increases drastically from about 6% in the age group 20-29 years, to 50-70% in the age group 40-79 years. Its incidence has been projected to increase significantly to over 320 million by the year 2025.[3] A study in southern Indian rural population showed 21.15% of the male subjects were diagnosed to have one or more sexual disorder and in that prevalence of erectile dysfunction was found to be 15.77%.[4]

Although lifestyle modifications and psychotherapy are considered as the first-line of treatment in ED, pharmacotherapy along with psychotherapy gives better results. Thus, medical management of ED is of significant importance. Ayurveda recommends the usage of drugs with Vrushya property in the management of Klaibya (ED).

Gokshurakadi Churna[5] is one such Vrushya Yoga with Madhura, Snigdha, Jeevaniya, Brihmana and Manoharshana properties. Gokshurakadi Churna was made into granules form for better palatability. The subjects of Klaibya is said to regain the capacity of indulging in the sexual activity by administration of this Yoga. Hence Gokshurakadi Churna was selected for the study.

Materials and Methods

Method of collection of data: Data was collected using specially prepared case report form.

Screening of the patient: A screening form was prepared with all the aspects of history, signs, and symptoms of Klaibya (Erectile Dysfunction)

Diagnostic Criteria: Among Screened Subjects, Klaibya was diagnosed based on the Lakshana’s such as Linga Shaitilya (flaccidity of penis), Mogasankalpachesta (futile sexual activity), Mlana Shishna (lack of erection due to loss of rigidity).[6] Erectile dysfunction diagnosed as per International Index of Erectile Dysfunction (IIEF).[7]

Inclusion Criteria

1. Minimum 3 months history of erectile dysfunction who are in a stable, monogamous relationship with a female partner.
2. Age-21 to 60 years.
3. Fairly good glycaemic condition HbA1C < 8%
4. Those subjects ready to participate and follow the instruction and sign the informed consent form

Exclusion Criteria

Subjects with,
1. Any systemic disease with impaired cardiac, hepatic and renal functions that may interfere with the course of treatment.
2. Significant anatomical penile deformity requiring surgical correction.
3. Failure to achieve erection after radical prostatectomy or pelvic surgery.
4. Penile Implants.

Sampling Technique: Convenient Sampling

Sample size: 20

Statistical Method: Paired Sample T test is used to analyze the significance of change in Scale data

Ethical clearance and CTRI registration: The ethics clearance certificate from the Institutional Ethics Committee of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan was obtained, with, IEC No: SDM/IEC/43/2022. Trial was registered on Indian clinical trial registry, CTRI/2023/07/055562.

Study design: Open label single arm prospective clinical study with pre and post-test design, from outpatient department of a tertiary Ayurveda hospital attached to Ayurveda medical college located in district headquarters in Southern India.

Intervention
Dose: 6 gms twice daily (Morning and night), After food

Route of administration: Oral

Anupana: Warm Milk (100ml)

Duration: 30 days

Source of medicine and authentication: Raw drug was procured from the vendor and authenticated at Dravya Guna department at Sri Dharmasthala Manjunateshwara College of Ayurveda and Hospital, Hassan.


Gokshurakadi Churna Granules

SNName of the drugBotanical NamePart usedProportions
1.GokshurakaTribulus terrestris Linn.Fruit1 Part
2.IkshurakaAsteracantha longifolia Linn.Seed1 Part
3.SathavariAsparagus racemosus Linn.Root1 Part
4.KapikacchuMucuna pruriens Linn.Seed1 Part
5.Nagabala MulaSida veronicaefolia Linn.Root1 Part
6.Atibala mulaAbutilon indicum Linn.Root1 Part
7.Sarkara2 Parts
8.Go-GritaQ.S

Assessment Criteria

Study parameters include International Index of Erectile Dysfunction Questionnaire (IIEF-15) with domains Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction.

Overall Satisfaction were assessed giving suitable scoring at three intervals namely 1st, 15th and 30th day of treatment.


Table 1: International Index of Erectile Dysfunction (IIEF-15)

Q. no.QuestionariesResponse
Q1How often were you able to get an erection during sexual activity?0 No sexual activity
1 Almost never or never
2 A few times (less than half the time)
3 Sometimes (about half the time)
4 Most times (more than half the time)
5 Almost always or always
Q2When you had erections with sexual stimulation, how often were your erections hard enough for penetration?0 No sexual activity
1 Almost never or never
2 A few times (less than half the time)
3 Sometimes (about half the time)
4 Most times (more than half the time)
5 Almost always or always
Q3When you attempted intercourse, how often were you able to penetrate (enter) your partner?0 No sexual activity
1 Almost never or never
2 A few times (less than half the time)
3 Sometimes (about half the time)
4 Most times (more than half the time)
5 Almost always or always
Q4During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?0 No sexual activity
1 Almost never or never
2 A few times (less than half the time)
3 Sometimes (about half the time)
4 Most times (more than half the time)
5 Almost always or always
Q5During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?0 Did not attempt intercourse
1 Extremely difficult
2 Very difficult
3 Difficult
4 Slightly difficult
5 Not difficult
Q6How many times have you attempted sexual intercourse?0 No attempts
1 One to two attempts
2 Three to four attempts
3 Five to six attempts
4 Seven to ten attempts
5 Eleven or more attempts
Q7When you attempted sexual intercourse, how often was it satisfactory for you?0 Did not attempt intercourse
1 Almost never or never
2 A few times (less than half the time)
3 Sometimes (about half the time)
4 Most times (more than half the time)
5 Almost always or always
Q8How much have you enjoyed sexual intercourse?0 No intercourse
1 No enjoyment at all
2 Not very enjoyable
3 Fairly enjoyable
4 Highly enjoyable
5 Very highly enjoyable


Q. no.QuestionariesResponse
Q9When you had sexual stimulation or intercourse, how often did you ejaculate?0 No sexual stimulation or intercourse
1 Almost never or never
2 A few times (less than half the time)
3 Sometimes (about half the time)
4 Most times (more than half the time)
5 Almost always or always

Observations

Table 2: Demographic profile of 22 patients of Klaibya (Erectile Dysfunction)

Age groupFrequencyPercent
21-2514.5
26-30522.7
31-35522.7
36-40313.6
41-45418.2
46-5029.1
51-5529.1
Total22100.0

Table 3: Distribution of subjects based on symptom Lingashaitilya and Mogasankalpachesta

Lingashaitilya and MogasankalpachestaFrequencyPercent
Present22100.0

Table 4: Distribution of subjects based on symptom Mlanashishna

MlanashishnaFrequencyPercent
Absent1568.2
Present731.8
Total22100.0

Results

Table 5: Paired Samples T test for Erectile function

Paired Differencestdfp valueRemarks
MeanSDSEM95% Confidence Interval of the Difference
LowerUpper
Pair 1Erectile Function BT - Erectile Function D15.500.513.115.260.7404.35919< 0.05S
Pair 2Erectile Function D15 - Erectile Function AT.500.513.115.260.7404.35919< 0.05S
Pair 3Erectile Function BT - Erectile Function AT1.000.562.126.7371.2637.95819< 0.05S

Table 6: Paired Samples T test for Orgasmic Function

Paired Differencestdfp valueRemarks
MeanSDSEM95% Confidence Interval of the Difference
LowerUpper
Pair 1Orgasmic Function BT - Orgasmic Function D15-.250.444.099-.458-.042-2.51719< 0.05S
Pair 2Orgasmic Function D15 - Orgasmic Function AT-.200.523.117-.445.045-1.71019< 0.05S
Pair 3Orgasmic Function BT - Orgasmic Function AT-.450.605.135-.733-.167-3.32719< 0.05S

Table 7: Paired Samples T test for Sexual Desire

Paired Differencestdfp valueRemarks
MeanSDSEM95% Confidence Interval of the Difference
LowerUpper
Pair 1Sexual Desire BT - Sexual Desire D15-.400.598.134-.680-.120-2.99019< 0.05S
Pair 2Sexual Desire D15 - Sexual Total AT-.350.671.150-.664-.036-2.33319< 0.05S
Pair 3Sexual Desire BT - Sexual Desire AT-.750.786.176-1.118-.382-4.26519< 0.05S

Table 8: Paired Samples T test for Intercourse Satisfaction

Paired Differencestdfp valueRemarks
MeanSDSEM95% Confidence Interval of the Difference
LowerUpper
Pair 1Intercourse Satisfaction BT - Intercourse Satisfaction D15-1.5501.191.266-2.107-.993-5.82019< 0.05S
Pair 2Intercourse Satisfaction D15 - Intercourse Satisfaction AT-.9001.021.228-1.378-.422-3.94319< 0.05S
Pair 3Intercourse Satisfaction BT - Intercourse Satisfaction AT-2.4501.099.246-2.964-1.936-9.96919< 0.05S

Table 9: Paired Samples T test for Overall Satisfaction

Paired Differencestdfp valueRemarks
MeanSDSEM95% Confidence Interval of the Difference
LowerUpper
Pair 1Overall Satisfaction BT - Overall Satisfaction D15-.250.550.123-.507.007-2.03219< 0.05S
Pair 2Overall Satisfaction D15 - Overall Satisfaction AT-.450.759.170-.805-.095-2.65119< 0.05S
Pair 3Overall Satisfaction BT - Overall Satisfaction AT-.700.923.206-1.132-.268-3.39019< 0.05S

Discussion

The paired samples t-tests evaluate changes in various sexual health domains across baseline (BT), day 15 (D15), and after treatment (AT). Significant improvements were observed in Erectile function, with mean differences of 0.500 (BT to D15, D15 to AT) and 1.000 (BT to AT), demonstrating the treatment's efficacy in addressing the issues (p < 0.05).

In Orgasmic function showed improvement. The improvements were statistically significant across all pairs, with a cumulative mean difference of 0.450 (BT to AT, p < 0.05). Similarly, Sexual desire experienced a significant improvement (0.750, BT to AT), similar improvement was noted from D15 to AT.

The most substantial reductions occurred in Intercourse satisfaction (-2.450, BT to AT), indicating persistent dissatisfaction despite physiological improvements. This may reflect psychological or relational challenges. Overall satisfaction demonstrated modest changes, with early-phase results not significant (BT to D15), but later improvements (D15 to AT and BT to AT) were significant, with a total reduction of -0.700.

Probable effect of Gokshuradi Churna Granules on Klaibya

The trial drug has shown significant improvement in patients with Klaibya. Its probable mode of action can be attributed to its Madhura Rasa, Guru and Snigdha Guna, Madhura Vipaka, and Sheeta Veerya. According to classical texts, Acharya Charaka highlights Guru and Snigdha Guna as key characteristics of Vrishya Dravya’s. These properties are similar to those of Shukra. The drug effectively addresses sexual dysfunction by alleviating Vata Dosha - the root cause of Klaibya - through its Guru and Snigdha Guna. Furthermore, due to its Vrishya, Balya, Brimhana, and Vajikara, Manoharsana properties, the formulation strengthens and improves erectile function.

Role of Gokshurakadi Churna Granules on Erectile Function

Steroidal saponins, such as protodioscin, furostanol, neotigogenin, tigogenin, gitogenin, neogitogenin and diosgenin, are considered to be the main active component of T. Terrestris. The saponins fraction has positive influence on testosterone production and improves libido and erectile function.[8] T. terrestris was shown to support hormonal function via the conversion of protodioscine to dehydroepiandrosterone (DEHA), which is the base molecule for the synthesis of testosterone.[9] Furthermore, diosgenin exerts a well-known protective effect on micro-circulation, and therefore, chronically using Tribulus could improve erectile function[10] Mucuna pruriens, has a long history of use in traditional medicine. Its seed extract has been extensively studied for the treatment of erectile dysfunction (ED). The ethanolic extract of M. pruriens seeds has been found to improve sexual performance in both healthy animal models and in models of diabetes-induced ED. Additionally, the extract has demonstrated effectiveness in protecting and restoring penile tissue from oxidative stress in animal models. There are also reports of M. pruriens extract stimulating aphrodisiac activity and potentially reversing spermatogenic loss in infertile men.[9]

There is highly significant result in erectile function. The relation between brain Dopamine and sexual behaviour are also well established. This drug contains L-Dopa, so the effect on Erectile Dysfunction may be due to its above chemical constitution. The drug enhances the blood circulation and produce general wellbeing by toning up the mental and physical functions. This might be the probable reason that there is significant improvement in Erection.[11]

Effect of Gokshurakadi Churna Granules on Sexual Desire, Orgasmic Function, Intercourse Satisfaction & Overall Satisfaction

Sexual desire is controlled by brain systems involved in sexual excitation and inhibition.


Hypoactive sexual desire disorder may result from hypo functional excitation, hyper functional inhibition, or some mix of the two. Brain dopamine systems that link the hypothalamus and limbic system appear to form the core of the excitatory system.

The multi-drug formulation helps to stimulate the activation of hypothalamic dopamine may be effective in stimulating sexual desire in animals and humans. Dopamine is involved in sexual gratification and mood elevation. Thus, it may help the Sexual Desire, Orgasm factor, Intercourse Satisfaction and overall satisfaction.[12]

Ghritha

Ghrita's Madhura Rasa and Madhura Vipaka makes it Shukravardhaka and also effective in balancing Vata. Its Guru and Snigdha qualities further promote Shukra through the principle of Gunasamanya.

As Ghrita balances both Vata and Pitta, it supports the neurological and vascular aspects of erection. Additionally, it plays a key role in the emission and ejaculation phases. Being Agnideepana in nature, it stimulates Agni, improving metabolism at the levels of Rasa, Rakta, Majja, and Shukra.[13]

Ksheera

Ksheera, with its Madhura and Snigdha Guna, is Shukrala and Vrshya. It has a direct influence on Shukradhatu, increasing its volume through Dravyasamanya. Being Ojasyam in nature, it boosts Veerya and Bala.

As a Dhatuvardhaka, it enhances both rasa and Shukradhatus due to its Saumya bhava. Its Vatapittahara properties helps in neurological and vascular aspects of erection and ejaculation.[14]

Conclusion

Gokshurakadi Churna granules has shown significant improvement with p<0.05 in Erectile function, Orgasmic function, Sexual Desire, Intercourse Satisfaction and Overall satisfaction domains in International Index of Erectile Function in 20 patients of Klaibya when given 6 gm twice a day with Ksheera (100ml) for a period of 30 days. Thus, Research hypothesis was accepted.

References

1. Sutrastana 7th Chapter. In: Paradakara Bhisagacarya HP, editor. Astanga Hridaya with Sarvanga Sundari of Arunadatta and Ayurveda Rasayana of Hemadri. Varanasi: Chaukhambha Sanskrit Sansthan; Verse 52. [Crossref][PubMed][Google Scholar]

2. Johannes CB, et al. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000;163:460-3. [Crossref][PubMed][Google Scholar]

3. Abolfotouh MA, Al-Helali NS. Effect of erectile dysfunction on quality of life. East Mediterr Health J. 2001;7(3):510-8. [Crossref][PubMed][Google Scholar]

4. Satyanarayana TS, Darshan MS, Tandon A. An epidemiological study of sexual disorders in South Indian rural population. Indian J Psychiatry. 2015;57(2):150-7. [Crossref][PubMed][Google Scholar]

5. Govind Das Sen K. Bhaisajya Ratnavali. In: Prabhakara Rao G, translator. Varanasi: Chaukhambha Sanskrit Sansthan; 2014. p. 685-6 [Crossref][PubMed][Google Scholar]

6. Acharya YT. Charaka Samhita. Varanasi: Chaukhambha Prakashan; 2011. p. 641 [Crossref][PubMed][Google Scholar]

7. Rosen R, Riley A, Wagner G, et al. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997;49:822-30. [Crossref][PubMed][Google Scholar]

8. Vyas JN, Niraj A. Text Book of Post Graduate Psychiatry. New Delhi: Jaypee Brothers Medical Publishers; 2005. p. 122 [Crossref][PubMed][Google Scholar]

9. Ștefănescu R, Farczadi L, Huțanu A, Ősz BE, Mărușteri M, Negroiu A, Vari CE. Tribulus Terrestris efficacy and safety concerns in diabetes and erectile dysfunction, assessed in an experimental model. Plants. 2021;10:744. [Crossref][PubMed][Google Scholar]


10. Neychev V, Mitev V. Pro-sexual and androgen enhancing effects of Tribulus Terrestris L. : fact or fiction. J Ethnopharmacol. 2016;179:345-55 [Crossref][PubMed][Google Scholar]

11. Semwal P, Painuli S, Abu-Izneid T, Rauf A, Sharma A, Daştan SD, Kumar M, Alshehri MM, Taheri Y, Das R, et al. Diosgenin: an updated pharmacological review and therapeutic perspectives. Oxid Med Cell Longev. 2022;2022:1035441. [Crossref][PubMed][Google Scholar]

12. Becker AJ, Uckert S, Stief CG, Scheller F, Knapp WH, Hartmann U, Jonas U. Cavernous and systemic plasma levels of norepinephrine and epinephrine during different penile conditions in healthy men and patients with erectile dysfunction. Urology. 2002;59(2):281-6. [Crossref][PubMed][Google Scholar]

13. Acharya YT, editor. Charaka Samhita of Agnivesha, revised by Charaka and Dridhabala, with the Ayurveda Deepika commentary of Chakrapanidatta. Sutrasthana, Chapter 13, Verse 14. Varanasi: Chaukhambha Sanskrit Sansthan;2001. [Crossref][PubMed][Google Scholar]

14. Charaka Samhita. Sutrasthana, Chapter 27, Verse 217. In: Acharya YT, editor. 6th ed. Varanasi: Chaukhambha Orientalia; 2001 [Crossref][PubMed][Google Scholar]

Disclaimer / Publisher's NoteThe statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of Journals and/or the editor(s). Journals and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content.