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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 5  |  Issue : 1  |  Page : 36-46

Efficacy of Phala Ghrita and cow ghee in the management of oligozoospermia: A comparative clinical study


1 Department of Kayachikitsa, CBPACS, Najafgarh, Khera Dabar, New Delhi 110073, India, New Delhi
2 Department of Kayachikitsa, Gujarat Ayurved University, Jamnagar, Gujarat, India
3 Department of Panchakarma, Gujarat Ayurved University, Jamnagar, Gujarat, India
4 Department of PTSR, IPGT & RA, Gujarat Ayurved University, Jamnagar, Gujarat, India

Date of Submission23-Jul-2021
Date of Acceptance10-Sep-2021
Date of Web Publication14-Dec-2021

Correspondence Address:
Dr. Jitendra Nathabhai Varsakiya
Department of Kayachikitsa, Chaudhary Brahm Prakash Ayurved Charaka Samsthan, Najafgarh, Khera Dabar, New Delhi 110073.
New Delhi
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jras.jras_13_21

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  Abstract 

BACKGROUND: Oligozoospermia is one of the major causes of infertility in males. A special branch of Ayurveda called Vajeekarana (aphrodisiac therapy) is specially related to management of infertility. Phala Ghrita (PHG) is an Ayurved formulation specially indicated in infertility due to oligospermia, and it is also narrated that cow ghee (CG) also possesses spermatogenic efficacy. Therefore, the present work was planned to compare the clinical efficacy of PHG and CG on oligozoospermia. MATERIALS AND METHODS: Ninety-nine male patients suffering from oligospermia and having sperm count less than 15 million/mL were selected for the study. Patients’ underwent Ayurveda Bio-cleansing procedure by using Haritakyadi Yoga–a laxative Ayurveda formulation. PHG and CG at a dose of 10 g, twice daily were administered in 51 and 42 patients, respectively, with warm milk for 8 weeks. Assessment of seminal parameters were done before and after completion of treatment. RESULTS AND DISCUSSION: Statistical data showed that PHG and CG showed a significant (P < 0.001) change in sperm such as increase in sperm motility, decrease in abnormal forms of sperm, and increase in semen volume. However, the effect of PHG is found to be better than CG except in increasing semen volume. CONCLUSION: PHG and CG both have significant spermatogenic potential when administered after bio-cleansing of body by using Haritakyadi Yoga. Study registration: CTRI/20164/01/006559

Keywords: Cow ghee, Haritakyadi Yoga, oligozoospermia, Phala Ghrita, Shodhana


How to cite this article:
Varsakiya JN, Goyal M, Thakar A, Donga S. Efficacy of Phala Ghrita and cow ghee in the management of oligozoospermia: A comparative clinical study. J Res Ayurvedic Sci 2021;5:36-46

How to cite this URL:
Varsakiya JN, Goyal M, Thakar A, Donga S. Efficacy of Phala Ghrita and cow ghee in the management of oligozoospermia: A comparative clinical study. J Res Ayurvedic Sci [serial online] 2021 [cited 2022 Jun 26];5:36-46. Available from: http://www.jrasccras.com/text.asp?2021/5/1/36/332441




  Introduction Top


In India, the prevalence of infertility is about 27.5 million with male factor infertility identified in approximately 50% of the cases.[1] Men start losing the quantity as well as quality of sperms soon after 30 years of age. Factors such as unhealthy lifestyles, diseases, injury, and hormonal imbalance are some of the leading causes for male infertility. It leads to endangered reproductive capacity of men, resulting in infertility conditions such as oligozoospermia. In Ayurveda, oligozoospermia is termed as Ksheena Shukra, and the Sanskrit term indicates decreased quantity of sperm in semen.[2] Management of infertility in modern medical science includes lifestyle changes, mainly maintaining weight; avoiding alcohol and tobacco; hormonal supplementation such as testosterone modulator (Clomid, Serophene) medications, antibiotics in case of infections and inflammation; multivitamins; and assisted reproductive techniques. Special branch of Ayurveda known as Vajeekarana (aphrodisiac therapy) deals with diagnostic and therapeutic aspects of infertility. The aphrodisiac therapy is considered more effective when done after bio-purification of body through Ayurveda penta-bio-purification methods.[3] In Ayurveda texts, there are several formulations narrated for the management of oligozoospermia, and among them use of Phala Ghrita (PHG) is indicated in male as well as female infertility. The formulation is claimed to have aphrodisiac and rejuvenating potential. According to the Ayurveda classical text and modern research, cow ghee (CG) also possesses similar qualities.[4],[5] Considering this fact, this comparative study was planned to evaluate the role of PHG and CG administered after bio-cleansing with Haritakyadi Yoga (HY) in the management of oligozoospermia.


  Materials and Methods Top


Male patients from the OPD of Kayachikitsa (general medicine), Institute for Teaching and Research in Ayurveda (ITRA), Gujarat Ayurved University (GAU), Jamnagar, having sperm count <15 million/mL and suffering from infertility for more than a year and gave written consent to participate in the trial were enrolled. Before recruitment of subjects in the present clinical trial, approval from the Institutional Ethics Committee was taken (Ref-PGT/7/-A/ethics/2015−16/2675, dated 11/12/2015) and was also registered in CTRI (CTRI/20164/01/006559).

Inclusion criteria

Male patients with age between 21 and 40 years having sperm count less than 15 million/mL[6] with clinical presentation of oligozoospermia, i.e., weakness, low ejaculation volume, and were suitable for Ayurveda bio-cleansing, were selected for the present study.

Exclusion criteria

Male patients age below 21 and above 40 years having sperm count more than 15 million/mL, known case of azoospermia and aspermia or suffering from varicocele, accessory sex gland infection, sexually transmitted diseases, any severe systemic diseases, etc. were excluded. Patients who had traumatic injury resulting to oligozoospermia were also excluded from the trial.

Laboratory investigation

Semen analysis

After recruiting the subject, semen analysis was conceded. Semen analysis was repeated after bio-cleansing and after 60th day of the treatment. Tests for biomarkers include follicle-stimulating hormone (FSH) and luteinizing hormone (LH), and testosterone levels were also carried out before and after the treatment. Routine hematological and urine examination was also carried out to assess the health status of the patients.

Method of semen collection

Before collection to avoid contamination, all the patients were instructed to clean the hands and glans penis thoroughly with tap water. Collection was done adjacent to the laboratory. Masturbation was recommended for the collection of semen sample because there are fewer chances for contamination and it provides the complete collection of ejaculate. Pre-cleaned, warmed, and labeled wide mouth containers, i.e., 50 mL glass beakers, were used for semen collection. If the patient fails to masturbate, a penile vibrator was used to induce the ejaculation. In case of failure of both of the aforementioned methods, collection by the coitus interrupts method was advised. The different timings of the day is having effect on the quality of semen.[7] To avoid such differences, the collection time was fixed between 8.30 a.m. to 9.30 a.m. throughout the study period. After collection, the semen samples were examined at room temperature for volume, percentage of motility, liquefaction time, sperm morphology, total sperm count, and presence of white blood cells.

Methods

The present clinical trial was an open labeled randomized study with efficacy as endpoint.

General status of patients according to the consolidated structure of the reporting clinical trial is depicted in [Figure 1].
Figure 1: CONSORT 2010 Flow Diagram for the present trial

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Grouping

The 93 male patients who were clinically diagnosed and confirmed as cases of oligozoospermia were randomly divided into two groups following the computer-generated randomization allocation chart which was obtained from http://www.randomization.com. Among them, two patients in Group A and four patients in Group B (total 6) dropped out. Out of the remaining 87 patients, 49 from Group A (PHG-treated) and 38 from Group B (CG-treated) completed the treatment.

Drug and posology

Patients in Group A were treated by using PHG at a dose of 10 g orally before food in the morning with a cup of warm milk and sugar once a day for a duration of 8 weeks. While in Group B, CG 10 g was administered orally before food in the morning with a cup of warm milk and sugar once a day for a duration of 8 weeks used as trial drugs.[8],[9] Details of grouping and posology are given in [Table 1].
Table 1: Drug and posology of the clinical study

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PHG was prepared in the Pharmacy of Gujarat Ayurved University.[10] Raw drugs of ingredients of PHG [Table 2] and HY for the study were procured from pharmacy and authenticated by the Pharmacognosy Laboratory of ITRA, Jamnagar. CG was procured from the local market Khadi Gram Bhandar of Jamnagar and of FSSAI-Certified brand. For the preparation of PHG, coarse powder of drugs mentioned in [Table 2] was taken in equal quantity and was fried in ghee, then four times of milk was added and cooked till evaporation of complete milk. Final product was analyzed in the pharmaceutical laboratory of ITRA, GAU, Jamnagar. Thereafter, the drug was packed in an airtight container and given to patients registered for study.
Table 2: Ingredients of Phala Ghrita

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Method of bio-cleansing[11]

Enhancing digestion and metabolism is a pre-requirement before bio-cleansing. Therefore, Trikatu Churna (an Ayurveda formulation) at the dose of 2 g, after food two times a day for 3 days, was administered. On the next day, CG at the dose of 40 mL was administered on an empty stomach with lukewarm water at 6 a.m. consequently for 7 days. Ghee was administered in an augmented pattern till the patient attained proper salutary oleation characteristics. After the finishing point of salutary oleation for the next 3 days, whole body massage by using Bala Taila and fomentation with Dashmoola Kwath were done for 3 days; two times in a day.[12] During these procedures, the patient was kept on normal diet with restriction on excessive spicy or heavy food items. On the day of bio-cleansing at morning time, mild purgative drug HY in the dose of 18 g (each in same amount) was given to patients on an empty stomach[13] [Table 3] and [Table 4].
Table 3: Ingredients of Haritakyadi Yoga

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Table 4: Details of bio-cleansing therapy

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Dietary regimen followed after bio-cleansing (DRBC)

After the completion of the bio-cleansing procedure, the patients were advised to follow specified dietary regimen narrated in the classical text of Ayurveda. The duration of dietary regimen was 3, 5, or 7 days based on the extent of bio-cleansing, strength, digestion, and metabolism capacity of patients, with diet including intake of thin gruel of rice, thick gruel of rice, and soup of vegetables and/or pulses in a sequential pattern as per Ayurveda guideline.[14]

General dietary and behavioral advises

Patients were advised to take fruits, green vegetables, and pulses in diet. Intake of garlic and onion, carrot, soya been, rice, corn, almond, milk and milk products was also advised. They were also asked to massage twice a day to the genital organ and try to be happy and cheerful in routine life and make harmony with partner.

Dietary and behavioral restrictions

Patients were advised to avoid smoking, alcohol consumption, excessive spicy, oily, salty, fatty diet, and intake cotton seed oil. Restriction was advised to behavioral activities such as bath with warm water, wearing tight costumes/undergarments, excessive mental exertion, exposure to sunlight, stress, long exposure to heat, and day sleep.

Criteria for assessment

Subjective criteria

The effectiveness of the therapy was measured on the basis of enhancement in the subjective and objective parameters. A suitable scoring pattern was adopted for the subjective parameters[15] (Appendix I). It includes sexual desire, erection, rigidity, performance anxiety, ejaculation, orgasm, overall satisfaction, erectile function, and post-act exhaustion.

Objective criteria

Parameters such as total sperm count, serum FSH, serum LH, and serum testosterone were also measured for objective assessment.

Statistical analysis

Statistical analysis was done by using the Wilcoxon signed-rank test for non-parametric paired data and paired “t” test for quantitative parametric paired data. Statistical computations were made with the help of Sigma Stat 3.5 software. The results were interpreted as significant (P < 0.05), highly significant (P < 0.01), very highly significant (P < 0.001), and insignificant (P > 0.05). The confidence interval was set at 95%.


  Results Top


In this clinical trial, a total of 93 male patients were registered, among them 87 patients completed the course of therapy which included 51 in Group A and 42 in Group B. Only six patients left the treatment, among them two left the course of treatment due to job transfer to other city, whereas others did not report for the treatment due to personal issues.

Effect of therapies on objective criteria

PHG provided statistically significant (P≤0.001) increase of 66.07% in total sperm count, 5.19% increase in sperm motility, 15.73% increase in normal form of total sperm, 40.62% decrease in abnormal forms, and increase in semen volume by 43.12%. CG also provided statistically significant (P≤0.001) increase of 80.92% in total sperm count, 41.78% increase in sperm motility, 12.58% increase in normal form of sperm, 41.69% decrease in abnormal forms, and 45.22% increase in semen volume.

Further analysis revealed that PHG (Group A) and CG (Group B) showed 66.07% and 68.87% increase in total sperm count compared between the periods of before treatment and after completion of period of DRBC, respectively (P≤0.01). About 51.84% and 37.76% increase in total sperm count were found when PHG- and CG-treated groups were compared between the DRBC and completion of treatment (P≤0.01). Observed increase in sperm motility before treatment and after DRBC is 39.58% in Group A and 38.55% in Group B. Increase in sperm motility after DRBC and after completion of treatment is 55.08% and 15.09% in Groups A and B, respectively (P≤0.01).

In contrast, percentages of abnormal sperms are found to be decreased by 24.95% and 27.88% in Groups A and B, respectively, when compared between before treatment and after DRBC. Further decrease in percentages of abnormal sperms by 24.85% in Group A and 20.74% in Group B is detected after comparing the results between DRBC and completion of treatment [Figure 2] and [Figure 3] and [Table 5] and [Table 6]. In both the groups, hematological and biochemical parameters remained within normal limits before and after the treatment.
Figure 2: Total effect on seminal parameters of therapies

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Figure 3: Effect of Virechana procedure and trial drugs on seminal parameters

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Table 5: Effect of therapies on seminal parameters of 87 patients of Ksheena Shukra

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Table 6: Comparison of effect of therapies considering before treatment and after treatment

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Hormones

Group A revealed 28.36% increase in serum FSH, 17.12% increase in serum LH value, and 16.54% increase in serum testosterone value. Group B showed 17.38% increase in serum FSH value, 26.63% increase in serum LH, and 25.84% increase in serum testosterone, which were statistically significant (P≤0.01) in both the groups. It indicates that PHG and CG act through stimulating the hormones like testosterone and therefore provide positive response on semen parameters [Table 7].
Table 7: Effect of trial drugs on hormone in 93 patients of oligozoospermia

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Effect of therapy on subjective criteria

Improvement is observed in parameters such as sexual weakness (80%, 16.66%), low quantity of semen (55.91%, 76.45%), sexual desire (76.90%, 78.02%), erectile dysfunction (70.92%, 75.71%), erectile rigidity (65.60%, 65.15%), orgasm function (72.72%, 79.22%), overall sexual satisfaction (81.74%, 81.74%), frequency of coitus (58.88%, 57.47%), duration of coitus (48.48%, 43.27%), and ejaculatory function (79.06%, 57.47%) in Groups A and B, respectively. The overall effect of therapies is depicted in [Figure 4].
Figure 4: Overall effect of therapies in 87 patients of oligozoospermia (Ksheena Shukra)

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  Discussion Top


Probable mode of action of bio-cleansing

For a healthy progeny, necessary things are proper time for conceive, normal ovulation period, healthy uterus, hormonal balance, and healthy sperm and ovum. Abnormality in any of these factors may lead to infertility. In day-to-day practice, it is noticed that low sperm count and defective spermatogenesis are the major reasons for infertility. The cause of such abnormality is either defective mechanism of testosterone or excess production of reactive oxygen specimen or both.[16] In Ayurveda texts, it is mentioned that the effectiveness of bio-cleansing therapy is helpful to alleviate most systemic diseases and restore the health.[17] The bio-cleansing method used in the present study is administration of mild laxative which helps to remove morbid matters from the body and equalize the diminished metabolism. This activity may help in normalizing the prognostic factors related to infertility.[18] From the observed effect, it can be claimed that DRBC and bio-purification of the body also have active roles in treating oligospermia and sperm motility.[19],[20]

Probable mode of action of PHG

The main ingredient of PHG is Asparagus adscendens, which contains Shatavarin and acts as aphrodisiac compound. This compound stimulates production of male gonadal hormones. The study of A. adscendens Roxb. on assessment of testicular spermatogenesis illustrated boosting mechanism on spermatogenic cells.[21] CG and cow milk are dispersion of fat globules and protein in solution of lactose, minerals, and other minor constituents. It activates the androgenic hormones within few minutes after administration. Cow milk is also a source of zinc and calcium.[22] Zinc possesses the antibacterial property which helps to reduce bacterial activity of seminal plasma, essential for sperm motility and linked to the morphology of sperm tails. In adolescent boys, zinc deficiency results in the retardation of growth and hypogonadism. Calcium is essential for the motility of spermatozoa. Oligospermia seems to be a sensitive indicator of zinc deficiency.[23]Pueraria tuberosa DC is another major ingredient of PHG which possesses aphrodisiac, rejuvenating, and spermatogenic potential.[24],[25],[26] By virtue of these properties, it helps to increases sperm count in patients of oligozoospermia. The previous study indicates that phytochemicals present in the P. tuberosa plant are capable of synthesizing reactive oxygen scavengers in infertile male albino rats particularly to repair the oxidative damage of spermatozoon characteristics.[27] Studies done on Withania somnifera (L.) Dunal showed that it enhances all the parameters of semenogram including testosterone and luteinizing hormone levels. W. somnifera also counters oxidative dent and stress and reverses the effect caused by smoking on sperms. The study of W. somnifera root extract suggested that naturally testosterone in W. somnifera root is much safer than artificial testosterone which many pharmaceutical products contain.[28] The low level of testosterone suggests qualitative impairment of spermatogenesis and perhaps defects in sertoli and Leydig cell function, which leads to reproductive impairment. Thus, testosterone is imperative in aiding the production of sperms.[29],[30]


  Conclusion Top


PHG and CG are effective in treating oligozoospermia. Efficacy of PHG is better than that of CG; however, due to less sample size, there is no significant difference detected. Further studies on large sample size are needed to explore detailed and comparative beneficial effect of these two interventions. Considering the expensiveness of anti-infertility medicine, it is the need of the hour to explore safe and cost-effective anti-infertility agents from herbal sources. Bio-cleansing with administration of HY following DRBC can shorten the duration of treatment of oligozoospermia by enhancing the pharmacodynamic and pharmacokinetic activities.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.





 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]



 

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