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CTRI Number  CTRI/2024/07/070805 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   STUDY TO ASSESS THE EFFICACY OF TWO ENEMA FOLLOWED BY INTERNAL MEDICINE IN THE MANAGEMENT OF LOW SPERM COUNT  
Scientific Title of Study   A Comparative Clinical Study to Assess the Efficacy of Sapta Prasrutika Basti and Mahamasha Taila Matra Basti followed by Vrushya Ghrita in the Management of Kshina 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 Kalidas V  
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room no: 111, PanchKarma Department, National Institute of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road Jaipur, Rajasthan, 302002 INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  9976406767  
Fax    
Email  ayurdas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipin Tanwar 
Designation  Assistant professor 
Affiliation  national institute of ayurveda dept. of Panchkarma  
Address  Chamber no 115, PanchKarma Department, National Institute of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road Jaipur, Rajasthan, 302002 INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  8239889891  
Fax    
Email  vipintanwarpk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kalidas V 
Designation  pg scholar 
Affiliation  National Institute Of Ayurveda,Jaipur 
Address  Room no: 111, PanchKarma Department, National Institute of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road Jaipur, Rajasthan, 302002 INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  09976406767  
Fax    
Email  ayurdas@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road Jaipur, Rajasthan. India. Pin: 302002. 
 
Primary Sponsor  
Name  National Institute of Ayurveda DU 
Address  National Institute of Ayurveda, Jorawar Singh Gate, Madhav Vilas Palace, Amer Road Jaipur, Rajasthan, 302002 INDIA 
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 kalidas vijayan   National institute of ayurveda jaipur   Department of panchkarma opd no. 2 madhav vilas jorawar singh gate jaipur rajasthan 302002
Jaipur
RAJASTHAN 		 9976406767

ayurdas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committe national institute of ayurveda e   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: KLAIBYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak sidhi 8/11, Procedure details: saptaprasrutik basti )
(1) Medicine Name: saptaprasrutik basti , Reference: charak sidhi 8/11, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 700(ml), Frequency: od, Duration: 14 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Mahamasha Taila (Chakradatta , Vatavyadhi Chikitsa - 192-200), Procedure details: Matra Basti will be administered to patient for 14 Days according to Kala Basti Schedule.)
(1) Medicine Name: Mahamasha Taila, Reference: Mahamasha Taila (Chakradatta , Vatavyadhi Chikitsa - 192-200), Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Male 
Details  1. Male patients age between 21-50 years.
2. Patients having sperm count below 15 million per ml.
3. Patients those are fit for Basti Karma (Niruha & Anuvasana) & Snehapana
 
 
ExclusionCriteria 
Details  1. Known case of various diseases like accessory sex gland infection,
2. Sexually transmitted diseases, severe systemic disease & Uncontrolled DM-II & HTN.
3. IHD, severe bilateral Varicocele, malignancy, Genetic disorders like Klinfelter’s syndrome.
4. Taking treatment for major psychiatric problem & Anti-epileptic drugs.
5. History of trauma leading to Oligozoospermia. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Changes in the sperm count
2. Changes in the volume, pH and viscosity of semen 		 Patient will evaluated on Day 0 and on Day 28 after procedures completed 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in the WHO Asessment criteria for Semen analysis  Day 0 & Day 28 
 
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 1 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="29" 
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  

·       Oligozoospermia is one among the prime factor in the male infertility.

·       In conventional system, various drugs indicated in oligozoospermia are expensive and produces several adverse effects like gynecomastia, hepatic carcinoma, deep vein thrombosis, dyslipidemia.

·       Acharya has mentioned the different Type of drugs for Ksheena Shukra. under Vajikarana Adhyaya. Clinical studies from many ayurvedic institute reveal that ayurvedic drugs are potentially effective in Oligozoospermia.

  Therefore, keeping all these facts in mind, it has been decided to conduct the study.

·       RESEARCH QUESTION: Is there any difference between the effect of Sapta Prasrutika Yapana Basti And Mahamasha  Taila Matra Basti followed by Vrushya Ghrita In the Management Of Kshina Shukra With Special Reference To Oligozoospermia?

·       NULL HYPOTHESIS (H0): There is no difference in the effect of Sapta Prasrutika Yapana Basti And Mahamasha Taila Matra Basti followed by Vrushya Ghrita in the management of Kshina Shukra (oligozoospermia)

·       ALTERNATIVE HYPOTHESIS (H1):  Sapta Prasrutika Yapana Basti along with Vrushya Ghrita is more effective than Mahamasha Taila Matra Basti followed by Vrushya Ghrita in the management of Kshina Shukra (oligozoospermia).

·       ALTERNATIVE HYPOTHESIS (H2): Mahamasha Taila Matra Basti along with Vrushya Ghrita is more effective than Sapta Prasrutika Yapana Basti followed by Vrushya Ghrita in the management of Kshina Shukra (oligozoospermia).

·       AIM: To compare the effect of Sapta Prasrutika Yapana Basti and Mahamasha Taila Matra Basti along with Vrushya Ghrita in the management of Kshina Shukra (Oligozoospermia).

·       OBJECTIVES: To assess the effect of Sapta Prasrutika Yapana Basti along with Vrushya Ghrita in the management of Kshina Shukra (Oligozoospermia).

·       To assess the effect of Mahamasha Matra Taila Basti along with Vrushya Ghrita by in the management of Kshina Shukra (Oligozoospermia).

·       To assess the comparative effect of Sapta Prasrutika Yapana Basti and Mahamasha Matra Taila Basti  along with Vrushya Ghrita in the management of Kshina Shukra (Oligozoospermia).

 
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