| CTRI Number |
CTRI/2024/05/067385 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Sukhaprasavkar lepa to facilitate Normal childbirth. |
|
Scientific Title of Study
|
Randomized controlled trial to evaluate efficacy of Sukhaprasavkar Lepa with Dinoprostone gel in the management of Prakrut Prasav with special reference to Induction 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 Swati Bhagwan Bali |
| Designation |
Associate Professor |
| Affiliation |
PMTs Ayurved college |
| Address |
Department - Prasutitantra and Strirog, PMTs Ayurved college, Aakhegaon road, Shevgaon, Dist, Ahmednagar, Maharashtra.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9273960901 |
| Fax |
|
| Email |
baliswati9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Bhagwan Bali |
| Designation |
Associate Professor |
| Affiliation |
PMTs Ayurved college |
| Address |
Deaprtment - Prasutitantra and Strirog, PMTs Ayurved college, Aakhegaon road, Shevgaon, Dist, Ahmednagar, Maharashtra.
MAHARASHTRA
414502
India |
| Phone |
9273960901 |
| Fax |
|
| Email |
baliswati9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Bhagwan Bali |
| Designation |
Associate Professor |
| Affiliation |
PMTs Ayurved college |
| Address |
department - Prasutitantra and Strirog, PMTs Ayurved college, Aakhegaon road, Shevgaon, Dist, Ahmednagar, Maharashtra.
MAHARASHTRA
414502
India |
| Phone |
9273960901 |
| Fax |
|
| Email |
baliswati9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Eknath Ayurved Rugnalaya and PMTs Ayurved College, Akhegaon Road, Shevgaon, Ahmednagar, Maharashtra, India, 414502. |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Prakash Kanade |
Sant Eknath Ayurved Hospital and PMTs Ayurved college |
Department of Prasutitantra and Strirog, OPD no 6, Akhegaon Road Shevgaon 414502.
Ahmadnagar
MAHARASHTRA |
9881413123
prkanade73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PMTs Ayurved college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O610||Failed medical induction of labor. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Prostaglandin E2 | Dose 0.5mg gel, Local application on vaginal wall, Duration - every 6 hours for 3 times, Total duration - 18 hours. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sukhaprasavkar Lepa, Reference: Bhavaprakash, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: qid, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Local application at Umbilical region every 6 hours for 3 applications Total duration 18 hours |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients in first stage of labour having one of the following indications for induction of labour. i.e.
a. Postdated pregnancy 41 weeks
b. At 39 weeks in low-risk pregnancy
c. Term prelabor Rupture of Membranes. (PROM) and Preterm Prelabor Rupture of Membranes (PPROM)
d. Hypertensive disorders in pregnancies. (Preeclampsia)
e. Fetal Growth restriction
|
|
| ExclusionCriteria |
| Details |
1 Patients contraindicated for Induction of Labour
2 Age below 18and above 40 years
3 Elderly primigravida (above 35 years) and Grand Multipara (G6)
4 Patients having Diabetes or Anemia (Hb less than 8gm)
5 Intrauterine Fetal Demise
6 Previous Cesarean section |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Monitoring of Progress of labour will be observed with help of Modified Bishops score
Mode of Labour will be observed - Normal Vaginal delivery or Cesarean section after 18 hours |
after 18 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Bishops Score |
after every 6 hours |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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 |
|
Date of First Enrollment (India)
|
24/05/2024 |
| 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="2"
Months="0"
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
|
In developed
countries, up to 25% of all deliveries at term now involve induction of labour.
In developing countries, the rates are generally lower. The study revealed
the prevalence of induction of labor in India to be 9%, which is very low in
comparison to the rate of other institutions in developed countries. Bishop’s score after cervical
ripening significantly predicted success of induction and induction was eight
times more likely to succeed if the Bishops score was Favorable. WHO Global survey on
Maternal and Perinatal Health, which included 373 health-care facilities in 24
countries and nearly 300000 deliveries, showed that 9.6% of the deliveries
involved labour induction. Our Acharyas have
described antenatal care (Garbhini Paricharya) for nine months of
pregnancy and has mentioned the use of enema (Anuvasan Basti) and
vaginal tampon (Yoni Pichu) of medicated oil prepared with drugs mentioned in Madhur
Sakandh 10 (group of drugs) during ninth month. Also, they described
various methods for sukhaprasava during labour; one of them is application of
herbal paste (Sukhprasavkar Lepas) at the onset of labour for easy and
safe delivery. The study was
designed to evaluate the effect of medicated pastes applied on and around
umbilicus named as Sukhprasavkar Lepa described by Bhavaprakash and Yogratnakara for evaluating effect on progress of
labour, cervical dilatation, Bishop’s score, duration of stages of labour and
pattern of uterine contractions for augmentation of labour. |