| CTRI Number |
CTRI/2025/08/093328 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF ERANDADI TAILA AND BALA TAILA MATRA BASTI IN MANAGEMENT OF SUKHAPRASAV |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of erandadi taila and bala taila matra basti in the management of sukhaprasav |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trisha Verma |
| Designation |
PG Schlor |
| Affiliation |
shree babu singh jai singh ayurvedic pg medical college |
| Address |
shree babu singh jai singh ayurvedic pg medical college and hospital fathegarh farrukhabaad
Balaganj lucknow
Lucknow
UTTAR PRADESH
209602
India |
| Phone |
7651838942 |
| Fax |
|
| Email |
trishav206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salim musa mulla |
| Designation |
Professor and HOD |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital |
| Address |
Bhaupur
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
7588627408 |
| Fax |
|
| Email |
drsmmulla@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trisha Verma |
| Designation |
PG scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital |
| Address |
shree babu singh jai singh ayurvedic pg medical college and hospital farukhabaad
lucknow balaganj
Lucknow
UTTAR PRADESH
209602
India |
| Phone |
07651838942 |
| Fax |
|
| Email |
trishav206@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Farrukhabad 209602 Uttarpradesh India |
|
|
Primary Sponsor
|
| Name |
Dr Trisha Verma |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College and Hospital Bhaupur Farrukhabad |
| Type of Sponsor |
Private 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 |
| Dr Trisha Verma |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital |
Room 6, division no 2, Department of striroga and prasuti tantra
Farrukhabad
UTTAR PRADESH |
7651838942
trishav206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri babu singh jay singh ayurvedic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
fair |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: PRAJAYANI-PRAJANANAKALAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: erndadi taila, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Balataila, Reference: bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida
completed 37 weeks
uncomplicated cases of pregnancy
single intrauterine gestation
with adequate pelvis
pregnant women willing for the trial |
|
| ExclusionCriteria |
| Details |
Pregnant women not willing for trial.
History of medical disorders during pregnancy such as; gestational diabetes mellitus
,pulmonary disease, renal disease, thyroid disorders, psychiatric illness, cardiac disease,
epilepsy, pre- eclampsia, eclampsia, malaria and HIV,bad obstetric history.
Absolute indication of caesarean section such as; central placenta praevia, contracted pelvis or
cephalo pelvic disproportion, pelvic mass, advanced carcinoma cervix and vaginal obstruction.
4. Anorectal diseases-fissure,hemorrhoids,fistula. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NORMAL DELEVERED BABY WITHOUT COMPLICATION. |
7 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NORMAL DELEVERED BABY WITHOUT COMPLICATION. |
24hr to 36hr |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/09/2025 |
| 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="2"
Days="15" |
|
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
|
when i give matra basti to our inclusive patient for 7 days in full term at 37 weeks than i want to compare my both drugs Erandadi taila and Bala Taila basti effect during labour for normal delivery without any complication . |