Evaluation of Kustha Choorna in the Management of Ksheena Shukra with Special Reference to Oligozoospermia

Introduction

The term ‘Shukra’ has a very wide concept in Ayurveda. A careful appraisal of the concept of Shukra is propounded by the classical Ayurvedic texts. The terms ‘Shukra’, ‘Virya’ and ‘Retas’ are generally used as synonyms and more or less used to denote ‘Semen’. ¹ Shukra is the 7th Dhatu and one among the Dasha Pranayatana. 2 It is also called as ‘Chatuspatha’ because it contains the Guna of Agni, Vayu, Prithvi and mainly Jala Mahabhuta.³ Ayurveda explains Ashta Shukra Dushti as conditions in the Shukra dhatu which have the potential to cause infertility. Ksheena Shukra is one of the varieties of Shukra Dushti. ¹

According to the Stedman, it is considered as the subnormal concentration of the spermatozoa in penile ejaculate. World Health Organization (WHO) defined it as the condition where the sperm concentration is ≥15 millions/millilitre (mil/mL). Except for some physical defects, low sperm count (Oligozoospermia) and poor sperm quality are responsible for male infertility in more than 90% of the cases. Out of these, in about 30 to 40%, the cause is unexplained and in the rest of the cases, critical illness, malnutrition, genetic abnormalities, pollution, side effects of some medicines, hormones, and chemicals play a major role.⁴

Dalhana commentator of Sushruta Samhita explains it as, “Ksheena Prajoutpadane na Samartha Bhavanti” i.e., loss of strength to procreate progeny.⁵ Synonyms of word Ksheena are Durbala, Krusha, Kshama, Tanu, Amamsa, Pelava. ⁶ Vata Prakopa in Shukra causes Oligozoospermia and premature ejaculation, Pitta Prakopa in Shukra in severe cases causes anti-sperm antibodies and Kapha Prakopa in Shukra Dhatu produces liquefaction disorders; with this logic, investigations are conducted for the diagnosis of Ksheena Shukra. ⁷ Oligozoospermia, a condition of low sperm count may associate with volume issues or viscosity problems. Virechana is the best choice in case of Vata pittaja Dusthi and it eliminates the Doshas from Adhobhaga by the route of Pakwashaya. Thus Vata Sthan associated with Pitta will get proper Shodhana and hence Vajikara effect of Kustha Choorna will be more effective after Shodhana. Kustha has the property of Shukra Shodhana, Shukrala and Vrushya.^8,9 Tikta Rasa will control Pitta, Ushan Veerya of Kustha controls Vata Dosha and Madhura Rasa controls both Vata and Pitta Dosha. Therefore, this is the choice of drug to administer for improving the quality and quantity of sperm after the Shareera Shodhana.

Aim

Evaluation of Kustha Choorna in the management of Ksheena Shukra, with special reference to oligozoospermia.

Objectives

1. To assess the efficacy of Kustha Choorna Rasayan after the Virechana procedure.
2. To review critically on aetiopathology, Roga Rogi Pareeksha and diagnosis of Ksheena Shukra as per Ayurveda and modern literature.

Materials and Methods

With an alternate hypothesis, thirty subjects were randomly selected and registered for the clinical trial from OPD of Taranath Government Ayurvedic Medical College, Hospital and Research Centre, Bellary. However, due to COVID-19 pandemic crisis, five subjects withdrew and the study was completed involving 25 subjects. Subjective and objective parameters were assessed by grading 0 to 3. No symptoms of Ksheena Shukra to mild, moderate and severe symptoms of Ksheena Shukra were considered with a follow up period of after Virechana and every 15 days of Rasayana up to 60 days and after assessment was done.

Source of data

• Male subjects with Ksheena Shukra (Oligozoospermia) were selected from the OPD, IPD of Taranath Government Ayurvedic Medical College, Hospital and Research Center, Bellary.
• Subjects were also selected from referral sources and special medical camps conducted for the purpose.

Study design

Descriptive data included mean, standard deviation (SD), interpretation of “t” value and P value were calculated for the variables in trial group by using paired t-test for objective parameters and Wilcoxon signed rank test was used for subjective parameters to compare two related samples.

Clinical trial: The trial obtained clearance from the institutional ethical committee (TGAMC/SS/02/2018 -19) and thereafter was registered retrospectively in the Clinical Trials Registry of India (CTRI/2020/ 12/029809, Registered on: 15/12/2020).

Diagnostic criteria

• Ksheena Shukra Lakshanas.

• Semen analysis parameters showing features of Oligozoospermia.

Inclusion criteria

1. Male subjects aged between 22-45 years.

2. Diagnosed cases of Oligozoospermia i.e., sperm count less than 15 million/mL.

Exclusion criteria

1. Subjects suffering with Azoospermia.

2. Congenital disorders related to reproductive system, like bilateral absence of the vas deferens, Cryptorchidism.

3. Subjects with history of sexually transmitted diseases (STD) and other systemic diseases like tuberculosis, uncontrolled type 1 diabetes, which interfere with the course of treatment.

Withdrawal criteria

Patients could withdraw from the trial anytime given the following reasons: Case with any health and safety issues, due to personal reasons, non-compliance, lost to follow up and randomization error.

Investigations

Semen analysis was done before treatment, after Virechana, and after 30 days of Kustha Rasayana. After treatment and for needy subjects, routine Complete Blood Count (CBC), General Random Blood Sugar (GRBS), androgenic hormonal and scrotal USG was done.

Assessment Criteria

Subjective parameters

Ksheena Shukra having no symptoms - Grade 0

Ksheena Shukra having mild symptoms - Grade 1

Ksheena Shukra having moderate symptoms - Grade 2

Ksheena Shukra having severe symptoms - Grade 3

Anga Daurbalya (cha su17/69), Mukhasosha (cha su17/69), Pandutvam (cha su17/69), Angasadana (cha su17/69), Shrama (cha su17/69), Shukra Kshayajanya Klaibya (cha su17/69), Shukraavisarga - Asamyaka Shukra Pravrutti ( cha su17/69), Phenila Shukram-Frothy (cha chi30/140), Tanu Shukram - Transparency (cha chi30/140), Ruksha Shukra-Acidic pH (cha chi 30/140), Kruchrena Alpa Shukra Pravartanam- Less quantity with difficulty in ejaculation (cha chi30/140), Saneela Shukram - Blue color semen (cha chi30/140), Sapeeta Shukram - Yellow color semen (cha chi30/140), Atyushma Shukram - Excessive hotness before/ during/ or after ejaculation (cha chi30/140), Pootigandha- Fetid smell in semen (cha chi30/140), Sadaha Shukram-Burning sensation before / during / or after the ejaculation (cha chi30/140).

Objective parameters

Semen analysis

Grading of sperm count of oligozoospermia

Mild low sperm count: 10 mil/mL - 15 mil/mL

Moderate low sperm count: 5 mil/mL - 10 mil/mL

Severe low sperm count: < 5 mil/mL

Intervention

• Dipana and Pachana with Panchakola Choorna (Sha Ma Kanda 6th chapter) 3 g TID for 4-5 days or until the Samyaka dipana pachana lakshanas are observed.
• Virechana schedule: Shodananga Snehapana Sneha Dravya- Murchitagritha test dose 40 mL fixed dose schedule as per patient 75 mL, 100 mL and 125 mL, respectively. Avara, Madhyama and Pravara need duration up to seven days or until Samyaka Snigdha Lakshana is observed. Vishrama Kala Abhyanga with Murchita Tila Taila Sarvangamridu Bhaspa Shweda for three days. Virechana with Abhayamodaka Vati 1 tab with cold water, Samsarjana Krama as per Shuddilakshana. 
• Kustha Choorna: Time of administration - morning, afternoon and night before food, Dosage - 500 mg cap, TID with warm milk, duration - 60 days, diet - regular, restriction - alcohol and smoking, etc.

Assessment of overall effect

To assess the overall effect of the therapies, net result obtained on various parameters of assessment both before and after treatment were taken into consideration. Then it was graded in terms of percentage of relief in symptoms.

Grading of remarks or criteria for assessment of overall effects of therapy

a) Complete cure - 100% relief

b) Marked improvement - 75% relief

c) Good improvement - 51% to 75%

d) Moderate improvement - 26% to 50%

e) Mild improvement - up to 25%

f) No relief / No change - 00%

Observations

Incidence based on subjective parameters

In this clinical study, it was observed that among the Ksheena Shukra Lakshanas, all the patients had low sperm count (100%) i.e., <15 mil/mL and in Sarvadaihika Lakshana, 84% presented with Angadaurbalya, 20% presented with Mukha Sosha, 28% of the total patients complained with Pandutvam. Angasadana or Angamarda and Shrama presented with clinically 64% and 72%, respectively. Among the Pratyatma Lakshana, Shukrakshayajanya Klaibya 20%, Tanu Shukra 52%, 16% Kruchrena Alpa Shukra Pravartanam, which is less quantity with difficulty during ejaculation. Sapeeta and Atyushma Shukra presented 8% and 12%, respectively.

In this study, no subject reported Shukra Avisarga, Phenila Shukra, Ruksha Shukra, Saneela Shukra, Pootigandha and Sadaha Shukra.

Incidence based on objective parameter (sperm count)

In this clinical trial, 48% of patients presented with moderate low sperm count, followed by 40% with severe low sperm count and finally three patients presented with mild low sperm count i.e. 12% of the trial cases.

Results

Descriptive data included mean, standard deviation (SD), interpretation of “t” value and P value were calculated for the variables in trial group by using paired t-test for objective parameters and Wilcoxon signed rank test was used for subjective parameters to compare two related samples. That included standard deviation, Z value interpretation, the corresponding P value was noted and the obtained results were interpreted.

Effect of trial drug Kustha Choorna on the subjective parameters

Discussion

Ksheena Shukra is Vata Pitta Prdhana, which is “Prajotpadane Asamarthaa Bhavati”. The line of treatment should be Vata Pitta Hara, Shukrala. In Charaka Samhita, it is mentioned that before the administration of Shukrala Dravya, one should go for proper Shareera Sodhana. Hence, in this clinical trial, Virechana was selected owing to its property of Adhobhaga Doshahara. ¹⁰ Vayu was located in Pakwashaya and Vayu in association with Pitta, pervades the entire body. In the treatment of Vata, Mridu Virechana is indicated.¹¹

Probable mode of action of drug

Kustha Choorna Rasayana was administered because of its property of Shukrala, Kustha (Sassuarealappa C.B.Clarke), Anushna Virya so Vata Kapha Hara, Deepana, Vishahara, Asthanopaga, Sthanyashodhaka, Lekhana. ¹⁰ It has antiseptic and disinfectant activity against Streptococcus and Staphylococcus, thus effective in Puthivivarna Shukradusthi. Because of Inulin, 18% sugars and starch, it is Madhura; hence Vatapittaja Shukradusthi Hara. Phytochemical analysis of S. lappa roots showed the presence of monoterpenes, sesquiterpenoids, flavonoids, lignans, triterpenes, steroids, glycosides and rich source of sesquiterpenoids, specially sesquiterpene lactones. Essential oil of S. lappa roots obtained by hydro distillation showed higher content of sesquiterpenoids (79.80%) than monoterpenoids (13.25%). Sesquiterpenoids have wide range of clinical applications.¹² Tikta rasa will control pitta, Ushna virya of Kustha controls Vata Dosha and Madhura Rasa controls both Vata and Pitta Dosha; so, this is the drug of choice to administer for improving quality and quantity of sperms after the Shareera Sodhana. Hence, to assess the Shukrala effect, Kustha choorna was selected and showed significant results in both subjective and objective criteria. Physiologically, spermatogenesis takes 74 days to form matured spermatozoa, where one cycle of the seminiferous epithelium is 16 days. Based on this logic, the duration of Rasayana is fixed and observed for the Rasayana effect.

Mode of action of Virechana in Ksheena Shukra

Virechana is the best choice in case of Vata Pittaja Dusthi and it eliminates the Dosha by the route of Pakwashaya. So, Vata Sthan which is associated with Pitta will get proper Sodhana. Hence Virechana helps to achieve Vajikara effect of Kustha Choorna very effectively after Sodhana.

Discussion on subjective parameters

In this clinical study, 84% of patients presented with Angadaurbalya after sexual intercourse with their partner for a short time, which may be relieved after having rest or gap in sexual act. In this study, most of the patients were not aware of Daurbalya, but after the intake of Rasayana, they observed the difference in their routine and noticed improvement in activeness and working capacity. Daurbalya is due to the Prakruta Kapha Kshaya; so Madhura Rasa of Kustha Choorna is responsible for the anabolic effect. The Inulin, essential oil, tannins, alkaloids and sugars are also responsible and due to smooth muscle relaxant action of sesquiterpenoids, Daurbalya can be relieved effectively in Ksheena Shukra patients and showed good result with P value <0.000. Mukasosha is due to Vata and Pitta Prakopa i.e., involvement of Ruksha and Ushna Guna, respectively during or after sexual intercourse where the dryness of mouth or oral cavity is due to Udakavaha Srotodusthi. In this clinical study, among 25 patients, 28% presented with Mukasosha with varying severity grading and at the end of the study, all experienced complete relief from Mukasosha with P value of <0.016. Kustha has Madhura Rasa (Jala, Prutvi Mahabutha) which added the effect to relieve the Mukasosha. Angasadana is due to Vata Prakopa in Shukra Dhatu and Kapha Kshaya. The trial drug Kustha Choorna Rasayana showed clinical significant result with P value <0.001 by the property of its Ushna and mitigate the Vata dosha. Shrama is due to Anga Daurbalya; the patients may not be able to perform work and may feel tiredness even with minor activity. In this clinical study, 72% cases presented with Shrama with varying levels of severity and trial drug Kustha Choorna Rasayana showed clinically significant result with P value <0.000. Kustha has the property of Kapha Vata Shamaka, but in this trial Anupana was chosen Dugdha and it is Kaphakara Shukrala Vatanulomaka and Sadhyobalakara; thus in this trial, Vatashamaka effect was appreciated by administering the trial drug.

Among 25 patients, only five patients presented with Shukra Kshayajanya Klaibya and the severity level was low; so the trial drug showed clinically significant result with P value <0.034. Tanu Shukra is well appreciated by the Pratyaksha Pareeksha of the semen due to the transparency or translucency may be due to decreased quality and quantity of sperm concentration by the Vata Prakopa in Shukra Dhatu. In this clinical trial, the Kustha Choorna with Dugdha Anupana showed clinically significant result with P value <0.001 and Vata shaman property of Kustha. In this clinical trial, among 25 patients, five patients presented with Kruchrena Alpa Shukra Pravartanam. Kustha Choorna Rasayana showed clinically significant result with P value <0.038. Kruchrena Alpa Shukra Pravartanam is due to the Vata Prakopa and Kustha Chrrona is Madhura Ushna, Vata Shamaka, Shukrasodhana and Shukrala effect showed clinically significant result in this study. Atyushma Shukra is Pitta Prakopa in Shukra Dhatu leading to hot flushes and due to Ushna Guna Vruddi, may cause burning sensation during or after ejaculation. In this clinical study, three patients presented with this Ksheena Shukra Lakshana and trial drug Kustha Choorna Rasayana demonstrated clinically significant result with P value <0.102. Virechana is Pittahara and Sadyoshukrakara, so after Virechana, Kustha Choorna Rasayana with Dugdha Anupana showed good result.

Discussion on objective parameters

Sperm count less than <15 mil/mL is Oligozoospermia, where both qualitative and quantitative reduction in sperm concentration is observed. In this clinical trial, it was observed that the trial drug showed clinically significant result with P value <0.001. Kustha is Tikta Madhura Rasa, hence Pitta Hara. Ushana Guna is Vata Hara and Shukra Sodhaka Shukrala Dravya. Among 25 patients, 60% of the patients presented with volume ranging between 0.5 to 2 mL, showing slight relation between the volume of the semen and Shukra Dusthi. In Rooksha type of Shukra, the quantity of semen is between 0.5 to 2 mL. In this clinical study, the trial drug showed clinically significant result with P value <0.001. Semen volume depends on the secretion of accessory glands. The increase in volume suggests that Kustha Choorna acted on the accessory gland and increased its secretions. The Kustha Choorna Rasayana is given after Sodhana with Murchit Gritha. This is Snigdha Guna in Vata Pitta Hara and controls Ruksha Guna of Vata Dosha that normalizes Chala Guna after the Kustha Choorna Rasayana, which is Shukrala and Vrushya that helps in improving the quality of sperm motility. In this clinical trial observed that sperm activity motility with P value <0.000 Sluggish Motility P value <0.05 and there was decrease in the dead sperm after the administration of Kustha Choorna Rasayana with P value <0.385.

Conclusion

Ksheena Shukra is a Vata Pittaja disease and majority of the patients are Madhyama Vayas with Vata Pittaja Prakriti. The disease was found in Janghala Desha as per the study conducted in Bellary. Kustha Choorna Rasayana significantly improved semen volume, sperm concentration and sperm motility by the action of Shukrala, Shukra Shodhaka with Tikta Madhura and Katu Rasa, followed by Ushna Virya and Katu Vipaka. The trial drug Kustha Choorna (Sassaurea Lappa C.B. Clarke) is rich in sesquiterpenoid lactones and are useful in the treatment of cardiovascular diseases, for counselling and building confidence in the patient. It can be added for good results along with Shukrala and Vrushya effect of Kustha Choorna Rasayana with Dugdha Anupana.

Conflict of interest

None