A Randomized open labelled Controlled clinical study to evaluate the efficacy of Kamadeva ghrita after Virechana Karma in Ksheena shukra with special reference to Oligospermia.

1.    Infertility is defined as a failure to conceive within one or more years of unprotected coitus (with adequate frequency i.e. 2-3 times a week).

2.     Approximately 20% of infertility cases are exclusively due to a male factor, with an additional 30% to 40% of cases involving male and female factors; therefore, a malefactor is present in one half of infertile couples.

3.     Oligospermia is among the prime factors in male infertility, and it is defined as a subnormal concentration of spermatozoa in the penile ejaculate.

4.   The prevalence of Oligospermia is amongst people who are accustomed to a sedentary lifestyle, alcohol addiction, Smoking, Caffeine intake and due to unhealthy food habits and irregular sleep Cycle.

5.   According to WHO  45% of Infertile Men were found to be affected by Oligospermia. And in India ,the prevalence is around 23% in 2017.

6.   Oligospermia stands near to the term Ksheena Shukra which is among eight types of Shukradushti mentioned in literatures*.*

7.   Commonly used pharmacological contemporary medicines include clomiphene citrate, tamoxifen, Hormone Replacement Therapies like FSH, HCG, Testosterone, which can cause various untoward effects like changes in libido, mood and energy level, weight gain, increased blood cell concentration and increased risk of blood clots.

8.   Recent advance of MART (Medically Assisted Reproductive Technologies) like artificial insemination, invitro-fertilization, and intra-cytoplasmic sperm injection, are not accepted widely in India due to social, economical concerns  and also the results are not very encouraging.

9.   ICD-1010-CM N46 is the billable/specific code that can be used to indicate the diagnosis of Oligospermia.

10.  Vajikaranais a branch of Ayurveda, deals with the promotion of sexual health, healthy progeny, treatment of infertility by increasing sperm count and motility.

11.  Although several research studies have been carried out, by keeping the prevalence of the disease and the importance of fertility in view, there is a necessity to find an economical and

effective formulation for the management of Ksheena Shukra with special reference to Oligospermia.

12.   Virechana karma is one of the prime treatment modality for Pitta,  It is one of the Shodana karma advocated prior to administering Rasayana and Vajeekarana.

13.  Kamadeva ghrita  mentioned in Sidda Sara sangraha in the context of Vajikarana  consists of Ashwagandha, Gokshura, Bala, Guduchi, Vidarikanda, Shalaparni, Shatavari, Shunti, Punarnava, Ashwatta, Gambhari, Kamala, Masha, Ikshu rasa, Meda, Mahameda , Jeevaka , Rishabaka , Kakoli, Ksheera kakoli, Riddi, Vriddi, Kushta,  Padmaka, Rakta Chandana, patra, pippali, Draksha, Kapikacchu, Nilotpala, Nagakesara , Ananta moola, Bala, Atibala, Ghrita and Sarkara . The properties of the ingredients like Vrishya and Brimhana seem to be promising in the management of Ksheenashukra.

14.   Hence, considering the above background, it was thought worthy to evaluate the efficacy of Virechana karma followed by oral administration of “Kamadeva ghrita” in the management of Ksheenashukra with special reference to Oligospermia.