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CTRI Number  CTRI/2024/07/069991 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
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   Role of Kamadeva ghrita after Virechana karma in Oligospermia. 
Scientific Title of Study   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. 
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 Akshay M L 
Designation  PG Scholor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  OPD No. 5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  8748914516  
Fax    
Email  akshaychandu1999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arif khan J S 
Designation  Associate professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  7676806222  
Fax    
Email  drarifkhansonofjs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arif khan J S 
Designation  Associate professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakpura Rd Udayapura PO OB Chudahalli Bangalore Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  7676806222  
Fax    
Email  drarifkhansonofjs@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research 21st KM, Kanakapura Road,Udayapura Post, Bangalore. Karnataka 560082 India 
 
Primary Sponsor  
Name  Dr Akshay M L 
Address  Dept of PG Studies in Kayachitsa ,Sri Sri College of Ayurvedic Science and Research 21st KM , Kanakapura Road, Udayapura post, Bengaluru  
Type of Sponsor  Other [[SELF]] 
 
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 Akshay M L  Sri Sri College of Ayurvedic Science and Research Hospital   Department of PG studies in Kaya Chikitsa,21st KM Kanakapura Road, Udaypura Post, Bengaluru.
Bangalore
KARNATAKA 
8748914516

akshaychandu1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE   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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kamadeva ghrita , Reference: Sidda Sara Sangraha, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Warm Milk), Additional Information: -Virechana will be done before giving Kamadeva ghrita. Control group - Phala ghrita .
2Comparator ArmDrugClassical(1) Medicine Name: Phala ghrita , Reference: Ashtanga Hridaya , Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm Milk), Additional Information: -Virechana will be done before giving Phala ghrita.
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.Subjects Diagnosed with Oligospermia
2.Subjects fit for Virechana karma.
3.Subject who are willing to give informed consent , which is conveyed in the language, which the subject can understand.
 
 
ExclusionCriteria 
Details  1.Subjects of azoospermia and aspermia
2.Subjects diagnosed with Sexually transmitted diseases.
3.Subjects diagnosed with Varicocele.
4.Subjects with Genetic disorders.
5.Subjects diagnosed with uncontrolled systemic disorders which might interfere in the course of disease and treatment.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant increase in Sperm count assessed based on Semen analysis.  0th,45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in depth analyzed data on the different aspect of disease  0th ,45th day 
 
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/ Phase 3 
Date of First Enrollment (India)   20/07/2024 
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="6"
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  

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.  Vajikarana is 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.

 
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