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
|
|
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
|
|
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.
|