| CTRI Number |
CTRI/2017/01/007664 [Registered on: 10/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of infertility in Ayurveda |
|
Scientific Title of Study
|
MANAGEMENT OF FEMALE INFERTILITY WSR TO TUBAL BLOCKAGE BY UTTARBASTI WITH APAMARGA KSHARA TAILA and PHALAKALYANA GHRITA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Patidar |
| Designation |
MS Ayu Research Scholar |
| Affiliation |
IPGT and RA Gujarat Ayurved University Jamnagar |
| Address |
Department of Strirog and Prasuti Tantra(Gynae and Obs) 5th floor IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008
Department of Strirog and Prasuti Tantra(Gynae and Obs) 5th floor IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9981092007 |
| Fax |
|
| Email |
sunilpatidar029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Laxmipriya Dei |
| Designation |
Professor and Head of Department |
| Affiliation |
IPGT and RA Gujarat Ayurved University Jamnagar |
| Address |
Department of Strirog and Prasuti Tantra(Gynae and Obs) 5th floor IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008
Department of Strirog and Prasuti Tantra(Gynae and Obs) 5th floor IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Donga |
| Designation |
Associated Professor |
| Affiliation |
IPGT and RA Gujarat Ayurved University Jamnagar |
| Address |
Department of Strirog and Prasuti Tantra(Gynae and Obs) 5th floor IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008
Department of Strirog and Prasuti Tantra(Gynae and Obs) 5th floor IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA GUJARAT AYURVED UNIVERSITY JAMNAGAR 361008 GUJARAT |
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
IPGT and RA Gujarat Ayurved University Jamnagar 361008 |
| 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 Sunil Patidar |
Department of streerog and prasutitantra IPGTRA Hospital Jamnagar Gujarat |
IPGTRA Hospital
GUJARAT AYURVED UNIVERSITY
JAMNAGAR
JAMNAGAR
361008
GUJARAT
Jamnagar
GUJARAT |
9981092007
sunilpatidar029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ithics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Tubal factor in Female Infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intrauterine uttarbasti of Apamarga Ksharataila and Phalakalyana Ghrita |
After deepan pachana and kostha shodhana then 5ml uttarabasti of apamarga ksharataila for 3 days then 3 days Gap and then 5 ml Phalakalyana Ghrita will be administered in form of intra uterine Uttarabasti (IUUB)once in a day for 3 days. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients of childbearing age (20-37yrs) with active marital life of 1 year or more, having complaint of failure to conceive with at least one fallopian Tube blocked diagnosed by H.S.G.
2 Having seminogram within normal limit of male partner.(>20 million/ml)
|
|
| ExclusionCriteria |
| Details |
1 Patients having age group below 20 years & above 37 years
2 Patients having any acute pelvic infection, hypersensitivity to chemical dye, congenital anomalies of vulva & vagina, Ca cervix, STD or any debilitating disease like TB, HIV, VDRL, HBsAg and TORCH positive will be excluded from study
3)Patients suffering from infertility due to male factor ie Oligospermia, Oligozoospermia, Azoospermia, Asthanospermia also be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uttarabasti of Apamarga Kshara Taila and Phalkalyana Ghrita is highly effective in management of Female Infertility wsr to Tubal blockage. |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
26/02/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/12/2016 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1 Deepan pachana with aampachana Vati and then Kostha shodhana with Eranda Bhrishta Haritaki 2 5ml uttarabasti of apamarga ksharataila for 3 days 3 After the gap of 3 days, 5 ml Phalakalyana Ghrita Uttarabasti once in a day for 3 days. This Protocol will be follow for 3 consecutive cycle. |