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CTRI Number  CTRI/2025/11/097155 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effectiveness of vidaryadi granules with and without detox therapy (Virechana) in improving low sperm count (oligozoospermia) 
Scientific Title of Study   Randomized comparative clinical study to evaluate the efficacy of VIDRAYADI granules with and without VIRECHANA karma in KSHEENA SHUKRA with special reference to OLIGOZOOSPERMIA 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Santosh kumar Ratre 
Designation  Post graduate scholar Department of prasuti tantra and stri roga 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of prasuti tantra and stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9303541547  
Fax    
Email  santoskumarratre677@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyotsna thakur  
Designation  Assistant professor  
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of prasuti tantra and stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8219232403  
Fax    
Email  thakurjyotsna16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyotsna thakur  
Designation  Assistant professor  
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of prasuti tantra and stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8219232403  
Fax    
Email  thakurjyotsna16@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santosh kumar Ratre  National Institute of Ayurveda Hospital Jaipur  Department of Prasuti Tantra and Stree Roga OPD 26 and 27 and IPD of National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN 		 9303541547

santoskumarratre677@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee National institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N468||Other male infertility. Ayurveda Condition: SUKRAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vidaryadi granules , Reference: Ashtanga hridaya Uttara tantra , Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: 200 ml milk and 10 ml Ghrita and madhu 5 grams), Additional Information:
2Intervention ArmProcedure-virecana-karma िवरेचन-कम (Procedure Reference: Charaka Samhita, Procedure details: Deepan pachana with 3-5 grams of Panchkola churna BD with water before food for 3-5 days Panchasakar Churna 5-10 gram HS if need Snehapana with Murchhita Goghrita 3/5/7 days as per patients koshthaSarwanga Swedana by vashpa/nadisweda with Dashmoola kwatha Virechana with Trivritta Avalehya Dose 60-90 gram as per need Sansarajana karma )
(1) Medicine Name: vidaryadi granules , Reference: Ashtanga hridaya Uttaratantra , Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Patient willing to participate in study for 3 months with monthly follow up
Patient having sperm concentration less than 15 million per ml
Patient having sperm concentration along with decreased motility and abnormal morphology and volume
Patient having normal thyroid function
 
 
ExclusionCriteria 
Details  Male patient below 21 years and above 45 years of age
Patient suffering from primary or secondary Azoospermia or Aspermia
Patient having history of Male reproductive accessory gland infection
Patient having history of previous scrotal or inguinal surgery
Patient having history of Testicular torsion cryptorchidism
Patient taking cytotoxic drugs alpha-blockers and spironolactone
Patient with known case of Hypertension and Diabetes mellitus COPD CKD cardiac diseases liver diseases Chronic Sinusitis
Patient known case of sexually transmitted diseases like Syphilis Gonorrhoea HIV or AIDS
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in parameters of Semen Analysis  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in score of IEEF Questionnaire
Changes in Hormonal Assay
 		 90 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

Vidarikanda is 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)

Pippali is 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 of Madhura, sheeta veerya, satmya, Shukravardhaka, Balya, Jeevaniya.

Ghrita is having properties of Pitta vatashamaka, shukra, ojavriddhikar.

Madhu is having properties of Ushna, Kapha samak, Vrishya.

Priyal is having properties of Snigdha guru sara madhur rasa and vipaka sheet veerya, vrishyavaajikara. It contains Maansatatwa, Starch, Sugar. (Dravya Guna Vigyan by Acharya Priyavrat Sharma)

Kokilaksha is having properties of Snigdha 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/Atmagupta is 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 of Ushna, Tikshna, Adhobhagahara, Virechaka .

 

Haritaki is having property of Pancharasatmaka, Doshaanulomana, Deepana-Pachana, Vrishya.

Vibhitaki is having property of  Kapha pitta shamaka.

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

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

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

Yavakshara

Research Question Is 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.

 
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