| CTRI Number |
CTRI/2020/03/024132 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
06/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic managment of tubal blockage |
|
Scientific Title of Study
|
Managment of female infertility w.s.r. to tubal blockage by ayurveda treatment protocol-A single arm open labelled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaddoriya Ektaben Bharatbhai |
| Designation |
MS 2nd year pg scholar department of prasuti tantra and stree roga |
| Affiliation |
Institute for post gradute teaching and research in ayurveda |
| Address |
5th floor Department of Prasuti tantra and Stree Roga New Building IPGT and RA Gujarat ayurveda university jamnagar Gujarat India
Opposite city B devision IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8487069680 |
| Fax |
|
| Email |
dr.ektavaddoriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Laxmipriya dei |
| Designation |
HOD Department of prasuti tantra and stree roga |
| Affiliation |
Institute for post gradute teaching and research in ayurveda |
| Address |
HOD office 5th floor Department of Prasuti Tantra and Stree Roga new building IPGT and RA Gujarat Ayurved University jamnagar GUJARAT India
Oppsite city B devision IPGT and RA Gujarat Ayurved University jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
Deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Laxmipriya dei |
| Designation |
HOD Department of Prasuti Tantra and Stree Roga |
| Affiliation |
Institute for post gradute teaching and research in ayurveda |
| Address |
HOD office 5th floor department of Prasuti Tantra and Stree Roga new building IPGT and RA Gujarat Ayurved University jamnagar GUJARAT India
Oppsite city B devision IPGT and RA Gujarat ayurved university jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
Deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for post gradute teaching and research in ayurveda gujarat ayurved university jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for post gradute teaching and research in ayurveda gujarat ayurved university jamnagar |
| Address |
IPGT and RA Gujarat Ayurved University Near GGH hospital 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 |
| Ektaben Vaddoriya |
Institute for post gradute teaching and research in ayurveda |
5th floor no 501 to 504 department of Prasuti tantra and Stree roga Institute for post gradute teaching and research in ayurveda gujarat ayurveda university jamnagar
Jamnagar
GUJARAT |
8487069680
dr.ektavaddoriya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee institute for post graduate teaching and research in Ayurveda Gujarat Ayurveda university Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N74||Female pelvic inflammatory disorders in diseases classified elsewhere, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
one cycle of uttarbasti along with oral therapy |
after stopping of menstrual bleeding uttarbasti for 6 days in which 1st to 3rd day with apamarg kshar taila 3 to 5 ml and 4th to 6th day with phalkalyan ghrita 3 to 5 ml done
ashwagandha churna 10 gram with 250 ml milk orally given for 7 days along with uttarbasti in empty stomuch daily in morning
total duration of oral drug-7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
37.00 Year(s) |
| Gender |
Female |
| Details |
1 patient with active marital life more than 1 year but failed to conceive with at least one fallopian tube blockage diagnosed by HSG and by any other methods
2 Patient suitable for Virechana Niruhabasti and Uttarabasti
|
|
| ExclusionCriteria |
| Details |
1 Patients having age group below 20 years and above 37 years
2 Patients having Carcinoma of reproductive tract
3 Patients having active inflammatory disease eg acute PID STD like HIV VDRL HBsAg HCV and TORCH positive
4 Patient having Congenital anomaly of reproductive tract
5 Patients having uncontrolled Hypertension DM and any other severe systemic disease
6 Women with Hb less than 7 gm%
7 Patients not suitable for Virechana Niruhabasti and Uttarabasti.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Opening of the Fallopian Tube |
40 DAYS |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Conception
Effect of Therapy in Menstrual Pathology i e Dysmenorrhoea Irregular Menses Oligomenorrhoea Endometrial Thickness
|
60 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
10/04/2020 |
| Date of Study Completion (India) |
25/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Fallopian tubes not mentioned directly in Ayurvedic texts, are included under the heading of Artava vaha srotasa and Fallopian tube blockage can be correlated with Artava vaha Srotodushti mainly Sanga type. It is part of the kshetra and essential for conception.Artava vaha srotasa covers all the physiological, functional and anatomical structures of female reproduction. Tubal blockage can be the consequence of various gynaecological disorders like: Yonivyapad, Artavadushti, Ashrigdara and Upadamsha.In modern the major cause of infertility related to tube prior PID,TB, Abortions, D&C / D&E. the main complication of the tubal blockage is female infertility which was found 25-35% similar to that of demographic data as mention in current scenario. Apamarga Kshara Taila removes the blockage by its Lekhana (scraping) property, Phalakalyana Ghrita for Ropana- re establish the function of (ciliary movement) fallopian tube by its ropana property and Ashwagandha churna helps in conception by balancing hormonal cycle. - 60% results was found in opening of the tube. - 33.33% results was found in conception. - 100% results was found in Alpartava (scanty menses) - 87.5% results was found in Yonivedana (dysmenorrhoea)
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