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CTRI Number  CTRI/2024/06/069412 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 22/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Ksheer Basti and Ksheerpaka on Diminishing Ovarian Reserve and Defective Endometrial Receptivity 
Scientific Title of Study   Pre clinical and clinical study to assess the role of Putrajeevakadi yoga with and without ksheerbasti on dhatukshayajanya bandhya w.s.r to diminishing ovarian reserve and defective endometrial receptivity  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashmi nema 
Designation  pg scholar 
Affiliation  National institute of ayurveda jaipur 
Address  Department of prasuti tantra eveum stri roga national institute of Ayurveda Deemed to be uiversity jorawar singh gate amer road jaipur Rajsthan 302002 india

Jaipur
RAJASTHAN
302002
India 
Phone  8234990335  
Fax    
Email  drrashmikori@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam choudhary 
Designation  Assistant Professor 
Affiliation  National institue of ayurveda jaipur 
Address  room no.302 3rd floor depratment of prasuti tantra evum stri roga national institute of ayurveda Deemed to be university jorawar singh gate amer road jaipur rajsthan 302002 india

Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax    
Email  poonam.18veena@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Poonam choudhary 
Designation  Assistant Professor 
Affiliation  National institute of ayurveda jaipur 
Address  room no.302 3rd floor department of prasuti tantra national institute of ayurveda Deemed to be university jorawar singh gate amer road jaipur rajsthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax    
Email  poonam.18veena@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Joravar singh gate Jaipur, 302002 
 
Primary Sponsor  
Name  National institute of ayurveda 
Address  Department of prasuti tantra evum stri roga National institute of Ayurveda Deemed to be university jorawar singh gate,Amer road jaipur rajsthan 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 
DrRashmi Nema  National Institute of Ayurveda Deemed to be University Jaipur  OPD NO 26-27 and IPD of |Prasuti Tantra evam Stri Roga Department National Institute of Ayurveda Deemed to be University Jorawar Singh Gate Jaipur Rajasthan
Jaipur
RAJASTHAN 		 8234990335

drrashmikori@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:N800||Endometriosis of uterus. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Putrajeevakadi yoga, Reference: Anubhuta yoga, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak chikitsha 28 / 191-192, Procedure details: ksheer Basti, matra basti)
(1) Medicine Name: ashwagandha, shatavari, bala, guduchi, yasthimadhu, Reference: anubhoot yoga, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 400(ml), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Patients having primary or secondary infertility will be selected.
2.Patient diagnosed as diminishing ovarian reserve as per Poseidon criteria or Defective
endometrial receptivity as per Applebaum score. 
 
ExclusionCriteria 
Details  1. Patients having age less than 21 years and more than 40 years.
2. Known case of Fragile x syndrome.
3. Patient suffering from disorders of reproductive tract like active Tuberculosis, Carcinoma.
4. Patient with anatomical defect.
5. Patient suffering from any chronic systematic illness like chronic anaemia, HTN (BP more than
140/90 mm Hg ).
6. Sexually transmitted diseases such as HIV, VDRL, HBsAg etc.
7. Patients Ayogya (contraindicated) for Yoga Basti.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Changes in endometrial receptivity on the basis of Appelbaum uterine scoring system
by USG Doppler
2) No. of follicle/ Basal AFC, Size of Dominant follicle by trans vaginal sonography
3) Changes in Basal serum AMH level.
4) Changes in LH/FSH value and ratio.
5) Changes in the Basal Serum Estradiol.
 		 two weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
1. conception rate
2. Improvement in menstrual disorder/problem, if present previously. 		 60 days for both groups 
 
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)   20/10/2024 
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="0"
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   RESEARCH QUESTION:
  Is there any difference in the effect of Putrajeeevakadi yoga with and without Ksheerbasti in the management of Dhatukshayajanya bandhya W.S.R. to Dimnishing ovarian reserve and defective endometrial receptivity.
 (Pre Clinical Study) Is there any difference in the effect Putrajeevakadi Yoga of with and without Ksheerabasti in the management of Dimnishing ovarian reserve and defective endometrial receptivity 

NULL HYPOTHESIS(H0) : There is no differnce in the effect of Putrajeevakadi Yoga with and without kheerbasti in the management of Dhatukshayjanya bandhya W.S.R. to Dimnishing ovarian resreve and defective endometrial receptivity.
 (Pre Clinical Study)  NULL HYPOTHESIS(H0): There is no difference in the effect in the effect of Putrajeevakadi yoga with and without ksheerbsti in the management of Dimnishnig ovarian reserve and defective endometrial receptivit 

ALTERNATIVE HYPOTHESIS (HA): There is difference in the effect of Putrajeevakadi yoga with and without ksheerabasthi in the management of Dhatukshayajanya bandhya w.s.r to Diminishing ovarian reserve and defective endometrial receptivity.
 (Pre Clinical Study) ALTERNATIVE HYPOTHESIS (HA): There is difference in the effect of Putrajeevakadi yoga with and without ksheerabasthi in the management of Diminishing ovarian reserve and defective endometrial receptivity.

 AIM: To evaluate the Effect of Putrajeevakadi yoga with and without Ksheerbasti in the management of Dhathukshayajanya Bandhya w.s.r to Diminishing Ovarian Reserve and def ctive Endometrial Receptivity. (Pre Clinical Study) AIM: To evaluate the Effect of Putrajeevakadi yoga with and without Ksheerbasti in the management of Diminishing Ovarian Reserve and defctive Endometrial Receptivity.
 
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