| CTRI Number |
CTRI/2021/08/035469 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Uttarbasti in tubal blockage |
|
Scientific Title of Study
|
Evaluation of Apamarga kshara taila with bala taila Uttarbasti in Bandhyatva(Tubal blockage) |
| Trial Acronym |
EAKTBTUB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja yadav |
| Designation |
Research scholar |
| Affiliation |
Rishikul campus haridwar |
| Address |
Department of prasuti tantra evam stree roga,Rishikul campus , haridwar
Department of prasuti tantra evam stree roga,Rishikul campus , haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8569853618 |
| Fax |
|
| Email |
pooja18894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr pravesh Tomar |
| Designation |
Professor |
| Affiliation |
Rishikul campus haridwar |
| Address |
Department of prasuti tantra evam stree roga,Rishikul campus , haridwar
Department of prasuti tantra evam stree roga,Rishikul campus , haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9557639649 |
| Fax |
|
| Email |
praveshtomarlal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja yadav |
| Designation |
Research scholar |
| Affiliation |
Rishikul campus haridwar |
| Address |
Department of prasuti tantra evam stree roga,Rishikul campus , haridwar
Department of prasuti tantra evam stree roga,Rishikul campus , haridwar
UTTARANCHAL
249401
India |
| Phone |
8569853618 |
| Fax |
|
| Email |
pooja18894@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Uttrakhnd Ayurved University |
| Address |
Uttrakhnd Ayurved University, Railway Road, Harrawala,Dehradun |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Pooja yadav |
Rishikul ayurvedic campus, haridwar uttarakhand ayurveda university |
Rishikul ayurvedic campus, haridwar uttarakhand ayurveda university
Hardwar
UTTARANCHAL |
8569853618
pooja18894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N971||Female infertility of tubal origin. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female of age group 20-40 year having infertility primary or secondary both due to tubal blockage |
|
| ExclusionCriteria |
| Details |
Congenital anomalies, sexual transmitted disease, urogenital infection,acute and chronic systematic and medical disease i.e,HTN and heart disease ,any abnormal growth (benign or malignant, Hepatitis B and HcV reactive |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Removal of tubal blockage and conception |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Removal of tubal blockage and conception |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
06/08/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Female infertility due to tubal blockage , by HSG finding of patients rule out tubal blockage and available treatment is laparoscopic surgery for removal of blockage this procedure is costely and not affordable for all patients. Present study aims, evaluation of Apamarga kshara taila with bala taila in Bandhyatva ( tubal blockage ) so that a safe and cost effective Treatment found . |