| CTRI Number |
CTRI/2025/12/099162 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
USE OF ADHATODA VASICA LOCAL APPLICATION TO START UTERINE CONTRACTIONS IS THE OUTCOME OF THE STUDY
BEYOND 41 WEEKS OF PREGNANCY |
|
Scientific Title of Study
|
STUDY THE EFFICACY OF EVOKE GEL (ADHATODA VASICA) LOCAL APPLICATION NABHI BASTI BHAGA TO INITIATE UTERINE CONTRACTIONS BEYOND 41 WEEKS OF GESTATION WITH SPECIAL REFERANCE TO LABOUR INDUCTION:OPEN RANDOMIZED CONTROL CLINICAL STUDY |
| 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 Meghana Anand Nikum |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali Maharashtra India |
| Address |
Roon No 8 Striroga and prasutitantra OPD Dhanwantari Hospital of Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali
Sangali
MAHARASHTRA
416301
INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
7038659268 |
| Fax |
|
| Email |
meghananikum131913mn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TinkuGanesh Prabhu Khalache |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali Maharashtra India |
| Address |
Roon No 8 Striroga and prasutitantra OPD Dhanwantari Hospital of Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali
Sangali
MAHARASHTRA
416301
INDIA
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TinkuGanesh Prabhu Khalache |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali Maharashtra India |
| Address |
Roon No 8 Striroga and prasutitantra OPD Dhanwantari Hospital of Hon Shri Annasaheb Dange Ayurved Medical College Ashta Sangali
Sangali
MAHARASHTRA
416301
INDIA
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Sangali Maharashtra
INDIA 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Meghana Anand Nikum |
| Address |
OPD No 8 of Striroga and Prasutitantra at Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reserch Centre Ashta Sangali Maharashtra |
| 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 Meghana Anand Nikum |
Hon Stri Annasaheb Dange Ayurved Medical College And Post Graduate Reserch Centre Ashta Sangali |
Dhanwantari Hospital Ashta Sangali Maharashtra Striroga and Prasutitantra OPD NO 8
Sangli
MAHARASHTRA |
7038659268
meghananikum131913mn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Reserch Centre Ashta Sangali Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: PRAJAYANI-PRAJANANAKALAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ADHATODA VASICA, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 100(mg), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Procedure -
1. Dissolve Methyl and propyl paraben in purified water at 80 degree celcius temperature and cool at room temperature.
2. To prepare a gel base, add 1 percent carbapol in step 1. Stirr continuously to get a uniform solution and add triethanolamine for adjusting the pH 5 to 7.
3. Add the extract to the prepared gel base with slow string to get uniform gel formulation,
Route of administration of drug, Local application (Nabhi, Basti, Bhaga) of Gel
Drug dose- 50-100 mg, Duration of administration,90 min | | 2 | Comparator Arm (Non Ayurveda) | | - | DINOPROSTONE GEL | Vaginal application of gel one time application or may be repeated after twelve to twenty four hours |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.In married women with age group of 21-35 years.
2.Post-term, post-maturity, post-dated pregnancy.
3.Singleton live pregnancy with normal AFI.
4.Cephalic presentation of fetus irrespective of gravida status.
5.Gestational age greater than 41 weeks.
|
|
| ExclusionCriteria |
| Details |
1.Gestational age less than 37 weeks
2.Contracted pelvis and cephalopelvic disproportion
3.Abnormal presentation
4.Active genital herpes infection
5.Previous uterine surgery like L.S.C.S, Fibroid
6.Gravida with systemic or other medical disorders.(DM,HTN)
7.High risk pregnancy including jaundice, preeclampsia, anemia, PIH
8.Precious pregnancy
9. Patients are excluded with no previous reports of CBC,USG |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of "Evoke Gel(ADHATHODA VASACA)" in initiating uterine contractions beyond 41 weeks of gestation in cases of labor induction. |
Ninety minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role of Dinoprostone gel vaginal application for induction of labor beyond 41 weeks of gestation |
Twelve to Twenty four hours |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
26/12/2025 |
| 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="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
|
Induction of labor is the initiation of uterine contractions before the spontaneous onset of labor with or without ruptured of membranes. By medical or surgical means for the purpose of delivery. It may be categorized as elective or indicated. In general, induction of labor may be indicated when the benefit of delivery to the mother and fetus outweighs the potential problem if the pregnancy continues. There may be maternal or fetal indications. These conditions may arise if the maternal medical or surgical condition worsens under expectant therapy or if there is evidence of impaired intrauterine existence. If obstetric data confirm that the pregnancy is at term or if fetal pulmonary maturity has been documented, the decision to induce labor is not difficult. When the cervix is closed and uneffaced, labor induction is often preceded by cervical ripening, a process to soften and open the cervix. This is somewhat of a misnomer in that cervical ripening, per se, may also be a means of labor induction. Prolonged pregnancy or postulates has been defined in the literature on the basis of weeks completed frogs the first day of the last menstrual period (LMP) Definitions have ranged from 41 to 43 completed weeks. The most often used definition is 42 completed weeks. The incidence of prolonged pregnancy has been reported to range from 3.5 to 14 percent of all pregnancies. Adhatoda vasica is a good source of pyrroloquinazoline alkaloids such as vasicine, vasicol, adhatonine, vasicinone, vasicinol, vasicinolone etc. Uterine stimulant activity and moderate hypotensive activity of the alkaloidshave been observed. Vasicine is metabolized to vasicinone. leaf extract showed that it contained 0.85 percent vasicine and 0.027 percent vasicinone. Adhatoda vasica possesses abortifacient and uterotonic properties due to the presence of vasicine in its extracts. The compound initiated rhythmic contractions of human myometrial strips from both non-pregnant and pregnant uterus. It indicating that the action of vasicine was probably enhanced by the synthesis and release of prostagladins. |