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CTRI Number  CTRI/2020/10/028461 [Registered on: 19/10/2020] Trial Registered Prospectively
Last Modified On: 16/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Unique Treatment ]  
Study Design  Single Arm Study 
Public Title of Study   EFFICACY OF INTRAUTERINE AYURVEDIC PROCEDURE IN INFERTILITY  
Scientific Title of Study   EFFICACY OF ‘UTTARBASTI’ USING COMBINATION OF PHALAGHRITA AND KSHAR TAILA IN INFERTILITY W.S.R. TO ENDOMETRIAL THICKNESS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neeta Mahesekar 
Designation  Professor (M.D., Ph.D.) 
Affiliation  dr. d.y.Patil, ayurved hospital and research Cenre 
Address  Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune
Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9822627092  
Fax    
Email  neetamahesekar19@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeta Mahesekar 
Designation  Professor (M.D., Ph.D.) 
Affiliation  Dr. D.Y.Patil, Ayurved Hospital and Research Cenre 
Address  Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune
Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9822627092  
Fax    
Email  neetamahesekar19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neeta Mahesekar 
Designation  Professor (M.D., Ph.D.) 
Affiliation  Dr. D.Y.Patil, Ayurved Hospital and Research Cenre 
Address  Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune
Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India 
Phone  9822627092  
Fax    
Email  neetamahesekar19@gmail.com  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil, Ayurved Hospital and Research Cenre, Pimpri, Pune 
 
Primary Sponsor  
Name  DRDYPATILVidyapeeth Pimpri Pune 
Address  DPU Vidyapeeth, Pimpri, Pune 411018 
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 Neeta Mahesekar  Dr.D.Y.Patil college of Ayurveda and Research centre, Pimpri, Pune  department of prasuti tantra and streeroga OPD2 Dr.D.Y.Patil college of Ayurveda and Research centre, Pimpri, Pune 411018
Pune
MAHARASHTRA 
9822627092

neetamahesekar19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, DPU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N972||Female infertility of uterine origin. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Uttarbasti  Uttarbasti using combination of Phalaghrita and Kshar Taila in infertility 1ml of phalaghrita 1ml of kshartail 1ml of phalaghrit total 3ml on the 6 7 8th day of menses for three consequitive cycles 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married females
18-40 yrs of age
Oligomenorrhoea
Endometrial thickness below 7mm.
Polycystic ovarian disease
 
 
ExclusionCriteria 
Details  Congenital abnormalities
Chronic systemic disorders
Pelvic inflammatory Disease
Cervical erosion
Leucorrhoea
Bleeding conditions
Carcinoma of the uterus ; Cervix & ovaries
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To prime endometrium for normal growth (7mm and above)  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
To introduce a cost effective treatment.
 
90 days 
 
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)   20/10/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Infertility has become a most significant problem nowadays with changing lifestyle, multitasking, stress & pollution . Infertility is a serious health issue worldwide, affecting approximately 8%–10% of couples worldwide.Of 60–80 million couples suffering from infertility every year worldwide, probably between 15 and 20 million (25%) are in India alone.According to a report by the World Health Organization (WHO), one in every four couples in developing countries is affected by infertility. Although genetic factor is also one of the cause but lifestyle remains the prime reason for infertility due to thin unhealthy endometrial where nidation and growth of the zygote suffers. With the availability of assisted reproductive techniques ,many couples opt for IVF which is an expensive treatment but sans healthy endometrium nothing is fruitful. The endometrium is primed by hormones for this purpose .For the same purpose Ayurveda offers Uttar Basti procedure,which fetched good results in pilot studies.

 â€˜Uttarbasti’ an important procedure unique to Ayurved; The  technique adopted is similar to Intra uterine insemination done while treating infertility in modern times. It is a powerful tool while treating majority of gynaecological disorders especially infertility.

 
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