| 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
|
|
|
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
|
|
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), |
|
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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 |
|
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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. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Dysmenorrhea
scanty menses
Regularization of cycle |
3 month |
|
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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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