1. What data in particular will be shared?
   Response (Others) -  NIL


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response (Others) -  NIL
   
3. Who will be able to view these files?
   Response (Others) -  NIL


4. For what types of analyses will this data be available?
   Response (Others) -  NIL


5. By what mechanism will data be made available?
   Response (Others) -  NIL


6. For how long will this data be available start date provided 16-07-2027 and end date provided 16-06-2030?
   Response (Others) -  NIL


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Ayurveda entitled as a “Divine science” due to its origin as well as its unimaginable potency in curing the diseases and protecting the health of a healthy person, physically and mentally. In Ayurvedic classics, Acharyas mentioned about four Purushaarthaas i.e. Dharma, Artha, Kaama and Moksha. Kaama, the desire is also related with sexual gratification, which is one of the happiness in the life and to create a healthy progeny. The essential factors of conception are Ritu (reproductive age and ovulation period), Kshetra (female reproductive tract), Ambu (nutritional factors) and Beeja (sperm and ovum) ¹. Any malfunction of these factors may lead to infertility. Acharya Charaka compares the man who is incapable of procreation as shadow less, single branched, foul smelling tree devoid of fruits that has no purpose or plays no role in the world².

 The ambition or aim of a person is that to propagate his legacy through his progeny. Infertility makes the man incapable for this. Ayurvedic classics have mentioned that the function of Shukra Dhaatu is reproduction³. There are eight types of Shukradusti according to classics⁴. A person having Shukradusti is unable to fulfil his Chaturvidha Purushaartha. Ksheena Shukra is one type of Shukradusti. It is Vata Pittaja Vyadhi, manifested as a result of Shukravaha Srotodusti and prevalence will be in Madhyama Vayas, being a disease from Apaana Vata province, in which decreased quality and quantity of Shukra Dhaatu is observed, which incapacitates him from conceiving his life partner, ending in Infertility.

Infertility is defined as a failure to conceive within one or more years of unprotected coitus⁵. Oligoasthenozoospermia is one among the prime factor in the male infertility and it is defined as a subnormal concentration of spermatozoa in the penile ejaculate with decreased sperm motility⁶. According to WHO guidelines on semen analysis, Oligoasthenozoospermia is the condition where the sperm concentration is less than 15 millions/milliliter⁷ with 40% of total sperm motility and 32% progressively motile sperm in the ejaculate. The condition Oligoasthenozoospermia can be well matched with Ksheena Shukra in Ayurveda.

Shukra Dhaatu is quantitatively and qualitatively vitiates in Ksheena Shukra and in Oligoasthenozoospermia there is quantitative reduction of sperms. According to Acharya Charaka, Ksheena Shukra and Shukra Kshaya are one and the same whereas according to Acharya Sushrutha and Acharya Vaagbhata, it is one among the Shukra Dushti in which Vata and Pitta are Vitiated⁸. Ativyavaaya, Ati Ruksha-Laghu-Ushna Aahaaras, Chinta, Shoka etc are considered as the Nidaanas^9,10,11,12 and Dourbalya, Mukhasosha, Paandutwa, Sadana, Shrama, Maithuna ashakti etc, are the Lakshanaas of Ksheena Shukra^13,14.

Infertility is global problem in the field of reproductive health. It is considered as a social stigma in India which ultimately affects the psychological harmony of the family, disturbed sexual and social life. ‘The incidence of infertility varies in different regions nearly 8-12% of couples worldwide. Of all infertility cases, approximately 40-50% is due to ‘male factor’ infertility and as many as 2% of all men will exhibit suboptimal sperm parameters. It may be one or a combination of low sperm concentration, poor sperm motility or abnormal morphology.¹⁵

As the sperm count decreases, there is corresponding decrease in likelihood of conception. Modern medical science has reached to its peak in MART (Medically Assisted Reproductive Technology), artificial insemination, invitro-fertilization, and intra-cytoplasmic sperm injection. These are considered as advanced technologies, but not accepted widely in India where poverty is rampant. So it is unable to provide service to all class of people in society, also it is not successful in even if infertile couple, they try again and again i.e. low success rate is the main fact. Ayurveda, the holistic medicine describes potent drugs and efficient therapeutic procedures to face the problem of infertility. Vajikarana, the eighth branch of Ayurveda mainly deals with the drugs and therapeutics which are aphrodisiacs in nature. It provides progeny to infertile couple, potency to the impotent, at the same time excellence of progeny with suitable therapeutic measures.Although a number of research studies have been carried out, by keeping prevalence of the disease in view, to find an effective and safe formulation for the management of Ksheena Shukra (Oligoasthenozoospermia), this research work has been undertaken, which is entitled as “A Randomized Controlled Comparative Clinical Study to evaluate the efficacy of Guduchyadi Churna over Gokshuradi Churna in Ksheena Shukra (Oligoasthenozoospermia).

The inspiration behind to take an herbal formulation “Gokshuradi Churna”¹⁶ mentioned in Chakradatta, Vrishyaadhikara (67^th Chapter) for the clinical study is based on the hypothesis that its ingredients Gokshura, Ikshuraka (Kokilaaksha), Shataavari, Vaanari (Kapikachu), Naagabala and Atibala having Vrishya property,  and “ Guduchyadi Churna”¹⁷ mentioned in Harita samhita, 27^th Chapter, Vajikarana adhyaya  ingredients Guduchi, Sathavari, swayangupta, Bala , Shalmali , Musali Mula  it may be useful for combating the Ksheena Shukra. The Anupana is Goksheera (cow’s milk) which is considered as Sadyovrishya and this Anupaana may be enhancing the properties of the drugs in the formula ‘Gokshuraadi Churna’ & ‘Guduchyadhi Churna’ along with its own action.