| CTRI Number |
CTRI/2023/08/057151 [Registered on: 31/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Bala Taila Matra Basti In The Management Of Vandhyatwa ( Infertility) |
|
Scientific Title of Study
|
Clinical Assessment To Evaluate The Efficacy Of Bala Taila Matra Basti In The Management Of Vandhyatwa (Infertility) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpuli Johari |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Jalukbari Ghy-14, Kamrup Assam |
| Address |
Department of Prasuti Tantra Evum Stree Roga Government Ayurvedic College and Hospital Jalukbari Guwahati Kamrup Assam 781014
Kamrup
ASSAM
781014
India |
| Phone |
9678656025 |
| Fax |
|
| Email |
arpulijoha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaushalya Khakhlary |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and Hospital Jalukbari Ghy-14, Kamrup Assam |
| Address |
Department of Prasuti Tantra Evum Stree Roga Government Ayurvedic College and Hospital Jalukbari Guwahati Kamrup Assam 781014
Kamrup
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushalya Khakhlary |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and Hospital Jalukbari Ghy-14, Kamrup Assam |
| Address |
Department of Prasuti Tantra Evum Stree Roga Government Ayurvedic College and Hospital Jalukbari Guwahati Kamrup Assam 781014
Kamrup
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Jalukbari Guwahati Assam 781014 |
|
|
Primary Sponsor
|
| Name |
Dr Arpuli Johari |
| Address |
Department of Prasuti Tantra Evum Stree Roga Government Ayurvedic College and Hospital Jalukbari Guwahati Kamrup Assam 781014 |
| 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 Kaushalya Khakhlary |
Government Ayurvedic College and Hospital Jalukbari Guwahati Assam 781014 |
Opd and Ipd of Prasuti Tantra Evum Stree Roga Department Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014 Kamrup Assam
Kamrup
ASSAM |
8638787369
drkaushalya01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt. Ayurvedic College, Guwahati, Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: Vandhyatwa, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta samhita /chikitsa sthan/35/89, Procedure details: Sthanik matra basti with Bala Taila for 7 days(after menstruation) each in 3 consecutive cycles. )
(1) Medicine Name: Bala Taila, Reference: Bhesajya Ratnavali 26, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients with chief complaints of unable to conceive even after a year of unprotected coitus |
|
| ExclusionCriteria |
| Details |
1) Patients with any pelvic pathology such as menorrhagia, fibroid, adenomyosis, endometriosis, PID, malignancy of pelvic organs etc.
2) Patients suffering from a cute infections
3) Patients with Systemic diseases like Diabetes Mellitus, CKD, HIV, Tuberculosis etc. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To make ritu, kshetra, ambu, beeja healthy
Able to conceive
To normalise the amount of blood loss
Normalise the interval between two cycles
To normalise the Duration of bleeding |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ultrasonography of lower abdomen to be within normal limit
HSG
TSH T3 T4
Serum prolactin
Haemoglobin |
90 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS AN EFFECTIVENESS OF BALA TAILA IN THE FORM OF MATRA BASTI IN THE MANAGEMENT OF VANDHYATWA. THISID DONECOMPULSORY PART OF POST GRADUATE COURS. TOTALNUMBER OF PATIENTSTO BE STUDIED IS 30 WITH DURATION OF 3 MONTHS |