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CTRI Number  CTRI/2025/06/088120 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 02/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Role of Arjakadi Vatika with Phala Ghrita Matra Basti in Oligospermia. 
Scientific Title of Study   A randomized open-labelled comparative clinical study to evaluvate the efficacy of oral administration of Arjakadhi Vatika and Vanari Gutika with Phala Ghrita Matra Basti in Ksheena Shukra with special refernce 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 T K VENKATESH 
Designation  PG SCHOLAR 
Affiliation  Sri Sri College Of Ayurvedic Science and Research Hospital. 
Address  Opd No.5 Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km, Kanakapura Road Udayapura Post, Bengaluru, 560082 Karnataka.

Bangalore
KARNATAKA
560082
India 
Phone  7349583194  
Fax    
Email  7349583194v@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arif Khan 
Designation  Associate proffeser 
Affiliation  Sri Sri College Of Ayurvedic Science and Research Hospital. 
Address  Opd No.5 Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km, Kanakapura Road Udayapura Post, Bengaluru, 560082 Karnataka.

Bangalore
KARNATAKA
560082
India 
Phone  7676806222  
Fax    
Email  drarifkhansonofjs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arif khan 
Designation  Associate profeser 
Affiliation  Sri Sri College Of Ayurvedic Science and Research Hospital. 
Address  Opd No.5 Sri Sri College Of Ayurvedic Science And Research Hospital, 21st Km, Kanakapura Road Udayapura Post, Bengaluru, 560082 Karnataka.

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 T K VENKATESH 
Address  Dept of PG Studies in Kaychikitsa, 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 T K VENKATESH  Sri Sri College of Ayurvedic Science and Research Hospital  Department of PG Studies in Kaychikitsa,21st KM Kanakapura Road, Udayapura post, Bengaluru.
Bangalore
KARNATAKA 
7349583194

7349583194v@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: VAN, (2) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: VAN, (3) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: VAN, (4) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: VAN, (5) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: RETODOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-MATRA BASTI (Procedure Reference: ASTANGA HRIDAYA, Procedure details: MATRA BASTI FOR 1st DAY TILL 9th DAY ALONG WITH ORAL MEDICATION)
(1) Medicine Name: ARJAKADI VATI, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: , Dose: 500(mg), Frequency: bd, Duration: 30 Days
2Comparator ArmProcedure-MATRA BASTI (Procedure Reference: ASTANGA HRIDAYA, Procedure details: MATRA BASTI TILL 1st DAY TILL 9th DAY)
(1) Medicine Name: VANARI GUTIKA, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1.) Subjects diagnosed with Oligospermia
2.) Subjects between the age group of 21 to 50 years
3.) Subjects those are fit for Matra basti
4.) Subjects 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 , 30th day and 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in depth analyzed data on the different aspect of disease  0th , 60th 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   N/A 
Date of First Enrollment (India)   15/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

·         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). 

·         Oligospermia is among the prime factors in male infertility, and it is defined as a subnormal concentration of spermatozoa in the penile ejaculate. 

·         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. 

·         According to WHO 45% of Infertile Men were found to be affected by Oligospermia. And in India, the prevalence is around 23% in 2017. 

·         Oligospermia stands near to the term Ksheena Shukra which is among eight types of Shukra dushti mentioned in literatures

·         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. 

·         ICD-10-CM N46 is the billable/specific code that can be used to indicate the diagnosis of Oligospermia. 

·         Vajikarana is a branch of Ayurveda, deals with the promotion of sexual health, healthy progeny, treatment of infertility by increasing sperm count and motility. 

·         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 effective formulation for the management of Ksheena Shukra with special reference to Oligospermia.

·         In Shodana chikitsa Basti karma is considered as best treatment for Shukra dosha. Basti karma is Pradhana karma which is mentioned as Ardha chikitsa. 

·         Phala ghrita  mentioned in Astanga hridaya uttara sthana consists of  Manjistha, Kustha, Tagara, Haritaki, Bibhitaki, Amalaki, Sharkara, Vacha, Haridra, Daruharidra, Madhuka, Meda, Dipyaka (yavani), Katurohini, Payasya, Hingu, Kakoli, Ashwagandha, Shatavari, Ghrita, Ksheera.

·         Arjakadi vatika   mentioned in Bhaishajya ratnavali in the context of Veerya sthambaka Adhikara consists of Shweta musali, Kapikachhu,Shanka pushpi ,Nirgundi , Jayaphala , Lavanga , Vidanga , Gaja pippali , Chaturjata , Vamshalochana , Ananta moola , Shweta tulsi , Shatavari , Bhringaraj moola, Vidari kanda , Gokshura , Jatiphala. The properties of the ingredients are Vrishya and Brimhana seem to be promising in the management of Ksheenashukra.

·         Vanari gutika   mentioned in Yogaratnakara consists of Kapikachhu, Suvarna Sutashekara  , Twak ,Suvarna Makshika Bhasma , Pippali moola , Ela , , Nagakesara , Lavanga ,Pippali ,Shuddha Shilajatu , the properties of the ingrediants like Vrishya and Rasayana seem to be promising in the management of Ksheenashukra.

·         Hence, considering the above background, it was thought worthy to evaluate the efficacy of oral administration of Arjakadi vatikain the management of Ksheenashukra with special reference to Oligospermia.

 
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