| CTRI Number |
CTRI/2024/06/069077 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to compare the effect of Apamarga Vasa gel and dinoprostone gel on progress of the labour |
|
Scientific Title of Study
|
Comparative clinical study on the effectiveness of Yoni Lepa with Apamarga Vasa gel and dinoprostone gel in first stage of labour |
| 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 Bharti Yadav |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
8800180433 |
| Fax |
|
| Email |
bhartiyadav0808@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Bhat NV |
| Designation |
Professor and HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
gaya3hassan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Bhat NV |
| Designation |
Professor and HOD |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
9844437917 |
| Fax |
|
| Email |
gaya3hassan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka,PIN-573201 India Phone No-08172256460, E-mail - sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Thanniruhalla, Hassan, Karnataka, Pin-573201, India Phone No-08172256460, E-mail - sdmcah@gmail.com |
| 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 Bharti Yadav |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Prasuti tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan-573201
Hassan
KARNATAKA |
8800180433
bhartiyadav0808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O618||Other failed induction of labor. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Apamarga Vasa gel, Reference: Gadanigraha and Vangasena, Route: Vaginal, Dosage Form: Lepa Churna, Dose: 20(mg), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Apamarga Vasa Moola choorna will be made in gel form for yoni lepa during latent phase of labour and assessment of labour will be done with Bishops score and partograph | | 2 | Comparator Arm (Non Ayurveda) | | - | Dinoprostone gel | Dinoprostone gel 0.5mg/3 gms will be administred in posterior fornix in comaprison with Apamarga Vasa gel |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1.subject who fulfill the diagnostic criteria
2.single intrauterine gestation with vertex presentation
3.subject who are agree to participate and ready to sign the consent form |
|
| ExclusionCriteria |
| Details |
1.High risk pregnancy with hypertensive disorders, gestational diabetes mellitus, pulmonary disease, renal disease, psychiatric illness, cardiac disease, epilepsy, severe anemia
2.Diagnosed with HIV, HBsAg, and VDRL
3.Absolutevindication of caesarean section |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spontaneous onset of labour pain with progress and reduced duration of first stage of labour |
Assessment will be done at baseline and once in every 4 hours using bishops score and partograph. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| delivery of a live baby |
Approximate 12 hours of onset of labour pain. |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/07/2024 |
| 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 study is a single blind double arm comparative clinical trial to evaluate the possible effect of Apamarga Vasa moola yoni lepa in first stage of labour and to compare its possible effect with Dinoprostone Gel.
This study will be conducted at Inpatient department of Prasuti tantra and Stree roga at Sri Dharmasthala Manjunatheshwara ayurveda hospital, Hassan, Karnataka. Methods: During the latent phase of labour- Trial group- 20ml Apamarga Vasa gel will be applied to the posterior fornix at interval of 4 hours. Control group- dinoprostone gel 0.5mg will be applied to the posterior fornix at interval of 4 hours. Maximum 3 doses in both groups
Assessment of progress of labour will be done with bishop’s score and partograph in both groups. |