Today due to changes in life-style, humans are losing Vr.s.yatā (virility) i.e., potency physically, mentally, sexually and spiritually. Biomedicine doesn’t seem to sufficiently address this problem.
Although it would seem likely that it is somewhat difficult to assess the prevalence of erectile dysfunction (ED), it is claimed to affect as much as 10% of the male population. Above the age of 40, nearly 52% of men are affected. Despite this staggering incidence, few cases come to light. [1]
The prevalence of ED across the world has a great deal of variation around 9-69% with a trend of a clear increase of this disorder at older ages. In all studies, ED has a rather high rate from 20% to 40% for the ages 60-69 years old, some increasing after the age of 65 years. [2]
This requires two kind of therapeutic approaches: one, by administering the aphrodisiac drugs with supplementation of a nutritious diet to regain vigor and virility; second, by offering counselling to dispel mis-conceptions and wrong beliefs about sexual performance.
Here in this clinical study, an attempt has been made to see the efficacy and safety of the orally administered Pūga Khan.d.a preparation with that of a placebo in the treatment of patients with Klaibya (impotency).
Study objective
To evaluate the efficacy of Pūga Khan.d.a clinically on sexual health and seminal parameters
To ascertain if the administration of Pūga Khan.d.a is associated with any side-effects.
Study design and patient selection
This was a randomised, placebo-controlled and parallel study comparing Pūga Khan.d.a with placebo in married male patients aged between 21 years and 50 years, attending O.P.D of Department of Rasa Shastra and Bhaishajya Kalpana of Muniyal Institute of Ayurveda Medical Sciences., (M.I.A.M.S.) Manipal, irrespective of religion etc. who had presented the clinical symptoms of either infertility (primary/secondary) or sexual dysfunction.
An elaborative case taking proforma was specially designed for the purpose of incorporating all aspects of the disease in the Ayurvedic parlance.
Diagnostic criteria
All patients were diagnosed and assessed thoroughly on the basis of Ayurvedic classical signs and symptoms of Klaibya or Vandhyātva with detailed history.
Exclusion criteria
Unmarried patients and patients having heart disease, tuberculosis, sexual transmitted diseases and any organic defect in the penile region, taking treatment for major psychiatric problems etc., were excluded.
Study medication and dosage
All patients were divided into two groups according to the sampling method adopted,
Trial group (Group A)
In this group, 27 selected patients were studied. These patients were given Pūga Khan.d.a in the dose of 6 g/q.d. in empty stomach early morning. Water was given as Anupāna.
Placebo group (Group B)
In this group, 25 selected patients were studied. These patients were given Placebo capsules prepared with wheat flour in the dose of 500 mg/2q.d. in empty stomach early morning. Water was given as Anupāna.
Irrespective of the group, all patients were subjected to Mr.du Śodhana for 3 days by administering Triphalā Chūrna 5g with luke warm water at bed time before the administration of the medicine.
Duration of treatment
To ensure efficacy of the drug the present study advocates a minimum of 45 days medication.
Diet
Patients were kept under normal diet.
Follow-up
To confirm the result and to check for recurrence, patients were followed-up with observation once in 7 days upto 28 days, after the end of the 45 day medication.
Criteria for assessment
The assessment was performed on the basis of changes in seminal parameters and sexual health parameters observed before, during and after treatment. The obtained results were analysed statistically.
Scoring pattern
Improvement in sexual health, i.e., desire, erection, rigidity, ejaculation, orgasm were recorded and graded. [3]
Statistical analysis
The obtained data was analysed statistically and presented as mean ± standard deviation. The data generated during the study was subjected to Mann-Whitney ūtest to assess the statistical significance between the two groups.
Ethical clearance
Institutional Ethical Committee of M.I.A.M.S., Manipal approved the design of the study. Written consent was taken from each patient willing to participate before the start of the trial. Patients were free to withdraw their name from the study at any time without giving any reason.
Observations
A total of 51 patients fulfi lling the inclusion criteria were enrolled in the study. A total of 43 patients completed the 45 day study period and 8 patients dropped out prior to completion of the study, 27 patients were registered in Group A, among them 24 patients continued till end of the study and 3 patients discontinued. In group B, a total of 24 patients registered, among them, 19 patients continued till the end of the study and 5 patients discontinued [Figure 1]. The following was the demographic distribution of the patients: 27 patients (52.9%) were between 31 years and 40 years, 15 patients (29.4%) belonged to the age group of 2l-30 years. 9 patients (18%) were belonging to age group of 41-50 year. 25 patients (49%) of patients belonged to Hindu religion, 19 patients (37.2%) belonged to Muslim and 7 patients (14%) were Christians. 25 patients (49%) were labourers. 15 patients (29.5%) had Vaāta Pitta Prakr.ti, 23 patients (45%) were addicted to smoking, followed by 18 patients (35%) to alcohol, 13 patients (25%) to pan-masala and 8 patients (15.6%) to tobacco. Sexual life was found unsatisfactory in 65% and satisfactory in 18 patients (35%), while 48 patients (94%) patients had normal scrotal findings and 3 patients (6%) of them had abnormal findings. 44 patients (86%) patients showed normal epididymal findings. 38 patients (74.5%) had the history of masturbation and 41 patients (80%) of reported nocturnal emissions before marriage. Nearly 18 patients (35%) indulged in Ativyavaya while 15 patients (30%) had Īrs.ā, Chintaā, Shoka, Bhaya etc., and 13 patients (25.5%) had the history of taking Asaātmya, ViruddhaAāhara. 20 patients (39%) reported lack of erection while 15 patients (30%) patients reported primary infertility and inability to maintain erection.
Results and Discussion
The present study was aimed to design an effective, safe and affordable alternative treatment of Klaibya. The herbal combination Pūga Khan.d.a used in this study showed better improvement in sexual desire, penile erection and penile rigidity in the treated group. Such positive results were not observed in the placebo group [Table 1]. Majority of patients in the study, i.e., 49% were Hindus, which only reflects the higher population of this religion in the specific geographic area. Majority of patients, i.e., 53% were of an age group between 31 years and 40 years. Excessive sex indulgence and stress may be the reasons for this population to seek the help of the physician. About half of the patients were of labour class. More than their physical work, stressful life, life-style changes, lack of education may be the key factors here. Majority of patients were poor, lacked nutrition and led unhygienic life-style, which might have impacted their condition. About 70% of patients had one or the other addiction. Tobacco and alcohol both have adverse effects on the libido of the individual. It could be seen that the majority of patients visited were naturally having an unsatisfactory sexual life and had led < 10 years of married life. Majority of patients were engaged in masturbation and also had nocturnal emissions. Even though these are natural and normal, mis-conceptions related with it might have had adverse effects. Majority of patients had the complaint of lack of erection. In general, this is the reason for which the patient seeks the help of a physician. Effect of therapy of the prepared sample Pūga Khan.d.a was assessed by analysing the effect on sexual parameters and seminal parameters. To confirm the effect to be due to the drug, but not by chance or placebo effect, a control group with placebo administration was also selected. Considering the effect on sexual parameters, we observe statistically significant improvement on sexual desire, penile erection and orgasm in the treated group, where as placebo group did not show such positive results [Table 2].
A significant improvement P < 0.001 was seen in duration of coitus in the group treated by Pūga Khan.d.a. This again confirms the positive effect of study drug in comparison with placebo. A significant improvement in the duration of sexual act and frequency of sexual act were other desired positive effects of Pūga Khan.d.a [Table 1].
When we consider the effect on seminal parameters, the data clearly shows the therapeutic efficacy of Pūga Khan.d.a. Significant improvement in seminal volume, total sperm count, rapid linear progressive motility and slow linear progressive motility were observed in the treated group. Mild reductions in the number of immotile sperms were seen in the group of Pūga Khan.d.a. A marginal increase in seminal volume was observed in the treated group and an adverse effect was seen in the placebo group. Another interesting observation is that the viscosity of semen also shows an increase. When the total effect of therapy was analysed all the patients under the treated group had shown at least some amount of improvement. In about 58% of patients, moderate to marked improvement was observed. In the placebo group, no improvement was seen. All these observations confirm that Pūga Khan.d.a has certain efficacy on both the sexual and seminal parameters [Table 2]. It also improved psychological and physical health. These effects could be due to the various ingredients present in the formulation.
Over-all effect of therapy
In Group A (Pūga Khan.d.a treated group), majority of the patients, i.e., 41.66% had shown mild to moderate improvement and the remaining 16.66% patients showed marked improvement. In Group B (placebo treated group), no improvement could be seen in the selected parameters, some of the patients have even shown deterioration in their condition.
Probable mode of action of Pūga Khan.d.a
Many researchers have concluded that Areca catechu as having aphrodisiac property, [4] anti-aging property, [5] anti-oxidant property, [6] anti-inflammatory, analgesic action. [7] Pūga has an alkaloid, arecoline, which has some stimulating action on the central nervous system. Pūga has Kashāya, Madhura Rasa, Guru gun.a, Śīta vīrya, Kat.u Vipāka and is Tridośa Śāmaka. The ingredients like Śatāvari (Asparagus racemosus)[8] Vidārīkhan.d.a (Pueraria tuberosa),[9] Godugdha (cow’s milk),[10] Ghr.ta (ghee),[11] Goks.ūra (Tribulus terrestris)[12] āmalakī (Emblica officinalis),[13] Śr.n.gāt.aka (Trapa bispinosa)[14] have both aphrodisiac, immune adjuvant and antioxidant properties. The drugs like Candana (Santalum album),[15] Jat.āmām.sī (Nardostachys jatamamsi),[16] āmalakī (Emblica officinalis)[17] have memory enhancing, anticonvulsant properties in addition. The drugs like Dālcīni (Cinnamonum zeylanica), Elā (Cinnamonum cardamom), Tejapatra (Cinnamonum tejpata) and Nāgakesara (Meusa ferrea), Karpūra (Cinnamomum camphora), Lavan.ga (Syzegium aromaticum), Pippalī (Piper longum) etc., in addition to Dīpana (appetizer), Pācana (digestive) properties also have a stimulant effect. This judicious composition along with the consideration of availability prompted us to select the drug.
Conclusion
In conclusion, the trial drug Pūga Khan.d.a was superior to placebo in reducing the mean sign and symptom score of seminal parameters and sexual health over 45 days of therapy. The findings have clearly indicated that Pūga Khan.d.a has very good effect as a Vr.s.ya Dravya, which is confirmed by its action on both sexual health parameters and seminal parameters. Further, there were no clinically significant adverse reactions and the overall acceptance to the treatment was excellent.
Acknowledgement
The author would like to acknowledge the Chairman and Principal, Muniyal Institute of Ayurveda Health Sciences, Manipal, Karnataka
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