Randomized comparative clinical study to evaluate the efficacy of VIDRAYADI granules with and without VIRECHANA karma in KSHEENA SHUKRA with special reference to OLIGOZOOSPERMIA

Need of Study

The recent statistical data says that about one in six couple in the world are suffering from infertility and male infertility accounts for about 30-40% of these cases. In about 30% of infertile men no causative factor is found for decrease in sperm concentration or quality by common clinical, instrumental or laboratory means and the condition is termed “Idiopathic” They are often treated by variety of empirical medications or assisted reproductive techniques (ART) posing great financial burden although success in few as there is no direct medical or surgical intervention agreed to be effective In Ayurveda Acharyas have explained holistic approach to correct the shukra dhatu vitiation and mentioned many Ayurvedic formulation as Vaajikarana yoga to correct subfertility without any side effect.  As per Ayurvedic principles of treatment of Shukradushti, Shodhana should be done prior to use of oral vajikarana yoga. Therefore, Present study has been undertaken to evaluate the efficacy of Vidaryadi granules in Ksheena Shurkra  with or without shodhana by virechana karma with special reference to Oligozoospermia and has been entitled as RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDARYADI GRANULES WITH OR WITHOUT VIRECHANA KARMA IN KSHEENA SHUKRA WITH SPECIAL REFFERENCE TO OLIGOZOOSPERMIA

Rational for Selection of intervention/justification for Selection of trial drugs

The yoga/drug selected for study is vidaryadi granules which is mentioned as vidaryadi yoga in Astangahridayam, Uttartantra chapter 40, Vajkiaranavidhiradhyaya shloka number 21-22.

This Vidaryadi yoga contains Vidarikanda, Pippali, Shali, Priyala, Kokilaksha, root of kapikachchu which is mixed with honey, sugar and ghrita in appropriate quantity as mentioned in texts.

Vidaryadi Yoga- A. Hri. Uttartantra 40/21-22

Vidarikandais having properties of Guru, Snighdha, Madhura guna, madhura vipka, sheetaveerya, Vata-pitta shamaka, Brihaneeya, vrishya (Aphrodiasic) and stanyajanana. It contains carbohydrate and protein.  (Dravya Guna Vigyan by Acharya Priyavrat Sharma)

Pippaliis having properties of Laghu, snigdha, Tikshna, Katu Rasa, Madhura Vipaka Anushnasheetveerya, Kapha-vatashamaka, Vrishya, shukradaurabalyanashak. It contains Piperine, Piplartine, Sesamin, Piplasterol, Piperlonguminin, Steroid and Gycoside. (Dravya Guna Vigyan by Acharya Priyavrat Sharma)

Shaali Chawal is having properties Madhur Balya, vrishaya.

Sharkara is having properties ofMadhura, sheeta veerya, satmya, Shukravardhaka, Balya, Jeevaniya.

Ghritais having properties ofPitta vatashamaka, shukra, ojavriddhikar.

Madhuis having properties of Ushna, Kapha samak, Vrishya.

Priyalis having propertiesofSnigdha guru sara madhur rasa and vipaka sheet veerya, vrishyavaajikara. It contains Maansatatwa, Starch, Sugar. (Dravya Guna Vigyan by Acharya Priyavrat Sharma)

Kokilakshais having propertiesofSnigdha guru sara madhurras and vipaka sheet veerya, Balya Brihana. It contain albuminoid, some alkaline yellowish, sweet oil, diastase, lipsase and protease. (Dravya Guna Vigyan by Acharya Priyavrat Sharma)

Swagupta/Atmaguptais having properties *of Snigdha guru madhurtikta, madhur vipaka ushna veerya, vrishya-balya-bruhaman-kshaya-klaibyanasaka.*It Contains protein, fiber, mineral, calcium, phosphorus, Iron, sulfer, Magnese, Dopa, Glutathayon, Lesithine, Gailic acid, Glucose etc. (Dravya Guna Vigyan by Acharya Priyavrat Sharma)

Most of the ingredients of this yoga possess madhura rasa, madhura vipaka, and snigdha guna by virtue of these properties it will act as potent vata-pitta shamaka, balya, vrishya and will correct the lakshana of ksheena shukra.

Charaka Samhita Kalpasthana Chapter 7/ 37-38

Trivritta is having property ofUshna, Tikshna, Adhobhagahara, Virechaka .

Haritakiishaving property of Pancharasatmaka, Doshaanulomana, Deepana-Pachana, Vrishya.

Vibhitaki is having property of  Kapha pitta shamaka.

Amalakiis having property of Pancharasatmaka, Dosha anulomana, Deepana-Pachana, Vayasthapana.

Pippaliis having property of Laghu, snigdha, Tikshna, Katu Rasa, Madhura Vipaka, Anushnasheetaveerya, Kaphavaatshamaka, vrishyashukradaurabalyanashaka.

Vidangais having property of Kutu, Tikshna, deepana, kapha-vaata shamaka, ushna, laghu, Shushka, Vrishya, Naatisheet Naatiushna veerya, virechya-chkshushya.

Yavakshara

Research QuestionIs there any efficacy of Vidaryadi granules with and without virechana karma in Ksheena Shukra with special reference to Oligozoospermia?

Null Hypothesis [HO]

There is no efficacy of Vidaryadi granules with and without Virechana karma in Ksheena Shukra with special reference to Oligozoospermia.

Alternative Hypothesis (HA)

There is efficacy of Vidaryadi granules with and without Virechana karma in  Ksheena Shukra with special reference to Oligozoospermia and viceversa.