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CTRI Number  CTRI/2025/02/081283 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic management of oligospermia 
Scientific Title of Study   Efficacy of Kaunchadi Granules in Ksheena Shukra W.S.R. to Oligospermia - An Open Labelled Randomized Standard Control Clinical Trail  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kamal Kumar Sidar 
Designation  MS Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat

Jamnagar
GUJARAT
361008
India 
Phone  9300030178  
Fax    
Email  kamalsidar5@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd Grishma Solanki 
Designation  Lecturer 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat

Jamnagar
GUJARAT
361008
India 
Phone  9427753900  
Fax    
Email  grishmabams@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vd Grishma Solanki 
Designation  Lecturer 
Affiliation  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat

Jamnagar
GUJARAT
361008
India 
Phone  9427753900  
Fax    
Email  grishmabams@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat India pin 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Department of Prasutitantra evum Streeroga 5th floor institute building ITRA, Jamnagar Opp-B Division Police Station,Gurudwara Jamnagar Gujrat 
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 
DrKamal Kumar Sidar  Institute of Teaching and Research in Ayurveda  O.P.D. No.6 PTSR OPD Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT 
09300030178

kamalsidar5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Institute of Teaching and Research in Ayurveda, Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-clomiphene citrateclomiphene citrate is a drug of choice in male having low sperm count
2Intervention ArmDrugOther than Classical(1) Medicine Name: kaunchadi Granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 12(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
 
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/ml,Patient having sperm concentration along with decreased motility less than 50% & abnormal morphology and volume,Patient having normal thyroid function,Patient with or without clinical presentation of Ksheena Shukra like Daurbalya, Mukhashosha.
 
 
ExclusionCriteria 
Details  Patient suffering from primary or secondary Azoospermia or Aspermia,Patient having history of Male reproductive accessory gland infection, varicocele,Patient having history of previous scrotal or inguinal surgery,Patient having history of Testicular torsion, cryptorchidism,Penile trauma or Penis fracture (rupture of corpus cavernosum),Traumatic and non- traumatic spinal disorders,Patient Taking Cytotoxic drugs, alpha-blockers and spironolactone,Genetic disorders like Klinefelter syndrome,Patient taking treatment for major psychiatric illness,Patient known case of Hypertension (BP more than150/90 mmHg) and Diabetes mellitus (RBS more than 140 mg/dl), COPD, CKD, cardiac diseases, liver diseases, and Chronic Sinusitis,Patient known case of sexually transmitted diseases like Syphilis, Gonorrhea, HIV/AIDS.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To improvement in parameters of Semen Analysis   12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Hormonal Assay.
To improvement in the quality of life & in score of IEEF Questionnaire 
90 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 3 
Date of First Enrollment (India)   10/03/2025 
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="1"
Months="0"
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  

Kshinashukra is a burning problem of today’s era which not only affects the somatic part of body but also affect psychological health. Kshinashukra is variety of Shukradushti eventually leading to infertility and the same in biomedicine is referred as oligospermia. As per Ayurveda, oligospermia can be co-related with Kshinashukra. The prevalence of infertility in general population affects around one in eight couples of reproductive age, with a male factor being solely responsible in 20% and contributory in an additional 30% of cases.

The drugs that are selected in this research are Kaunchadi Granules which are selected as trial drug. And tablet clomiphene citrate standard drug In Kshinashukra mainly involvement of Vata Dosha. Kaunchadi Choorna possesses Vrishya property.Guptaphala (Kauncha)and Gokshura have Madhura Rasa, Guru, Snigdha Guna, Seeta Veerya, Vrishya, Rasayana, Brimhana and Vattapittahara properties. Uchchata (Bhumyamalaki) has Madhura, Tikta, Kashaya Rasa, Laghu, Ruksha Guna, Sheeta Veerya and Balya. Milk has Madhura Rasa, Guru, Snigdha Guna, Sheeta Veerya, Madhura Vipaka, Rasayana, Brimhana, Vattapittahara and Sharkara is having properties of Madhura, Sheeta Veerya, Satmya, Shukravardhaka, Balya, Jeevaniya.  All drugs have Vatapittahara property which helps in Samprapti Vighatana of Ksheena Shukra as it is Vatapitta predominant disease. However, Madhura Rasa, Snigdha, and Guru Guna increase the Shukra Dhatu qualitatively and quantitatively. It can increase the Testosterone by increasing the luteininzing hormone and the gonadotropin releasing hormone. Combination of drugs having adaptogenic, antioxidant, and aphrodisiac properties effectively have multifaceted sexual health benefits.

The following investigations will be carried out before & after treatment to rule out other pathogenesis and assessment the status of subjects. Semen Analysis- (Physical examination, Microscopic examination, Other abnormalities), Hematological Examination - Hb%, TLC, DLC, ESR, Urine –Albumin, Sugar & microscopic, Bio-chemical investigation- RBS, Sr.Testosterone test and Serology Examination (HIV, HBsAg, HCV, VDRL),special laboratory test (FSH, LH, TSH) USG of Abdomen and Pelvis, Scrotum (Only BT). The participation in this research is entirely voluntary. In this present research work, 30 clinically diagnosed patient of Ksheenashukra (Oligospermia) will be registered and randomly divided into two groups. In Group A, Patients will be given Kaunchadi Granules (trial drug) every morning before breakfast, orally, 12 grams with milk twice a day for 90 days.

 In Group B, Clomiphene citrate tablet orally, 1 tablet (25 mg) with water once a day after food for 90 days. The patient will be withdrawn from study if patient complains of any adverse reaction or having any serious complications occur due to treatment will be referred to the higher centre. The patient will be withdrawn if patient desires to be discontinued treatment protocol. If any adverse drug reaction will be observed then it will be reported to the ADR cell (Pharmacovigilance cell of ITRA, Jamnagar).

 

 

 

 

 

 
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