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CTRI Number  CTRI/2020/12/030096 [Registered on: 29/12/2020] Trial Registered Prospectively
Last Modified On: 08/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Rasontail matra basti in Anovulatory cycle 
Scientific Title of Study   Randomised controlled clinical study of Rasontail basti in Anovulatory cycle(Abijotsarga) (WHO CLASS2 CLASSIFICATION) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Uttam Pathade 
Designation  Reader 
Affiliation  YMT Ayurvedic Medical College and PG Institute Kharghar 4 
Address  OPD NO 6 Strirog prasutitantra deparmentYMT Ayurvedic Medical College andPG Institute Kharghar navi mumbai 4

Mumbai
MAHARASHTRA
410210
India 
Phone  7276175467  
Fax    
Email  swatipathade2011@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  dr seema mehere 
Designation  professor 
Affiliation  YMT Ayurvedical college PG institute Kharghar 
Address  opd no 6 streerog prasutitantra department YMT Ayurvedi medical college PG institute Kharghar Navi mumbai 4

Mumbai
MAHARASHTRA
410210
India 
Phone  9930940403  
Fax    
Email  seema.mehre@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dr seema mehere 
Designation  professor 
Affiliation  YMT Ayurvedical college PG institute Kharghar 
Address  OPD No 6 strrog prasutitantra departmentYMY Ayurvedi medical college PG institute Kharghar Navi mumbai 4

Mumbai
MAHARASHTRA
410210
India 
Phone  9930940403  
Fax    
Email  seema.mehre@gmail.com  
 
Source of Monetary or Material Support  
Y M T Ayurved medical college PG Institute kharghar 4  
 
Primary Sponsor  
Name  swati pathade 
Address  YMT Ayurvedic college and PG Institute kharghar 4 
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 SWATI PATHADE  YMT Ayurved medical college and PGi Institute  OPD NO 6 YMT AYURVEDIC MEDICAL COLLEGE AND HOSPITAL KHARGHAR NAVI MUMBAI 4
Mumbai
MAHARASHTRA 
7276175467

swatipathade2011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YMT Ayurvedic medical college and PG institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: Anovulation(Abijostgra),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rason tail matra basti  60 ml Rasontail matra basti will be given Aftrar emptying the bowel in the morning at 9 am from 5th day of menses till 10 days. for 3 months . Rrtaintion time of basti will be noted. 
Comparator Agent  Tablet Clomifen citrate 100 mg   t clomifen citrate 100mg will be given orally from second day of menses for next 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.PCOD
2.Irregular menses /Scanty menses due to Anovulation
3.Anovulation/Oligoovulation
4.Delayed Ovulation 
 
ExclusionCriteria 
Details  1. Bleeding P/V
2.cervical polyp, tumour, Ca Cervix
3. Uterine Fibroid
4.Congenital anomalies in female genital tract
5. Tubercular Endometritis
6.HIV/ VDRL/ HbsAg positive
7.Malignant diseased patient and Cytotoxic patient
8.Patient with all systemic disorders 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
efficacy of Rasontail matrabsti in anovulatory cycle whether the development of follicle ovulatation occurs on folicilar study  for 3 month . from 5th day of menses for 10 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Dysmenorrhea
scanty menses
Regularization of cycle 
3 month 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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 3 
Date of First Enrollment (India)   03/01/2021 
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  
Motherhood is an ultimate and cherished desire of every woman. when she achieves it, she feel completeness in her life but all woman are not so much lucky to attain motherhood.  This impact on individuals physical and mental health.Modern era is unable to give answer to her questions. the treatment suggested on modern science is though effective , has lots of side effects.Ovarian factors is second most common cause of infertility, contributing about 25 to 35%. here present study will be  based on the referrance available in Kashap samhita kalpsthana.Factors of anovulation will be confirmed by counselling,check up & investigation.Total 106 patient of anovulation will be taken in the study.out of which 53 patient will be subjected to clomiphene citrate and 53 patient will be subjected to the Rason tail matra basti.Tablet clomiphene 100 mg will be given from second day of menstrual cycle for 5 days orally.
 This the controlled clinical trial in which  Rason tail matra basti will be given to patient with anovulatory cycle.After emptying bowel in the morning,immediate after taking light food at morning at 9 AM,60 ml Rason tail matra basti will be induced to the patient,Retention time of basti will be noted.Basti will be given from fifth day of menses for 10 days .Treatment duration for 3 months.follow up period will be every menstrual cycle for three consecutive cycles.During the treatment total abstinence will be there.
Inclusion Criteria-
1) Age group 18 -35 yrs 2) PCOD 3) Irregular / Scanty menses due to anovulatory cycle4) Anriteriaovulation / Oligoovulation 5) delayed ovulation
Exclusion Criteria -
1)Bleeding PV 2)Cervical tumour-polyp,Ca cervix 3)Uterine fibroid 4) Congenital anamalies in female genital tract 5)Tubercular endometritis 6)HIV/VDRL/HbsAg positive 7)Malignant diseased and cytotoxic  patient 8) patient with all systemic disorders.
Hematological investigations will be done.USG pelvis and Follicular study will be done  from 10th day of menstruation till after ovulation with serum FSH,serumLH,serum oestadiol.
The improvment in the symptoms will be assess on the basis of severity.A)subjective criteria is quantity of menstrual bleeding . B)objective criteria 1) folicular size 2) Endometrial Thickness.statistical Analysis will be done by using appropriate stastistical techniques to prove the significance of result.the data will be collected from CRF were then subjected to demographic and statistical  analysis and conclusion will be drawn which will be unbiased.

 
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