CTRI/2024/06/069145 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On:
17/06/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Normal Delivery through Ayurveda
Scientific Title of Study
A Randomized comparative clinical trial to evaluate the
efficacy of Integrated and Ayurvedic protocol in achieving
Sukhaprasava.
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 Jyoti Singh
Designation
PG Scholar
Affiliation
National Institute of Ayurveda Deemed to be University(De Novo), Jaipur
Address
Department of Prasuti Tantra and Stri Roga, National Institute of Ayurveda, Deemed to be University(De Novo), Madhav Vilas Palace,Jorawar Singh Gate, Amer Road, Jaipur National Institute of Ayurveda, Deemed to be University(De Novo), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur Jaipur RAJASTHAN 302002 India
Phone
9554767875
Fax
Email
dr.jyotisinghms@gmail.com
Details of Contact Person Scientific Query
Name
Prof K Bharathi
Designation
Professor and HOD
Affiliation
National Institute of Ayurveda Deemed to be University(De Novo), Jaipur
Address
Third Floor, Department of Prasuti Tantra and Stri Roga, National Institute of Ayurveda, Deemed to be University(De Novo), Madhav Vilas Palace,Jorawar Singh Gate, Amer Road, Jaipur National Institute of Ayurveda, Deemed to be University(De Novo), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur Jaipur RAJASTHAN 302002 India
Phone
9492047131
Fax
Email
baruhunt@gmail.com
Details of Contact Person Public Query
Name
Prof K Bharathi
Designation
Professor and HOD
Affiliation
National Institute of Ayurveda Deemed to be University(De Novo), Jaipur
Address
Third Floor, Department of Prasuti Tantra and Stri Roga, National Institute of Ayurveda, Deemed to be University(De Novo), Madhav Vilas Palace,Jorawar Singh Gate, Amer Road, Jaipur National Institute of Ayurveda, Deemed to be University(De Novo), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur Jaipur RAJASTHAN 302002 India
Phone
9492047131
Fax
Email
baruhunt@gmail.com
Source of Monetary or Material Support
Nageshwar Pharmacy, National Institute of Ayurveda Deemed To be University,Jorawar Singh Gate, Jaipur, Rajasthan, India(302002)
Primary Sponsor
Name
National Institute of Ayurveda Deemed To be University, Jaipur
Address
Department of Prasuti Tantra and Stri Roga, National Institute of Ayurveda Deemed To be University(De Novo),Madhav Vilas Palace,Jorawar Singh Gate, Amer Road, Jaipur
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Jyoti Singh
National Institute of Ayurveda Deemed To be University, Jaipur
OPD No 26-27 and IPD of Prasuti Tantra and Stri Roga Department, National Institute of Ayurveda Deemed To be University(De Novo), Madhav Vilas Palace,Jorawar Singh Gate,Amer Road, Jaipur Jaipur RAJASTHAN
9554767875
dr.jyotisinghms@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee, National Institute of Ayurveda Deemed to be University ,Jorawar Singh Gate,Jaipur,Rajasthan(302002)
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: GARBINIROGAH,
(Procedure Reference: Modern Medicine, Procedure details: Tab. Misoprostol-25ug, Sublingual, After onset of labor & before 5-6
cm cervical dilatation (Min 1 - max 4 times)
) (1) Medicine Name: Bala Taila, Reference: Charak Samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: sos, Duration: 4 Weeks(2) Medicine Name: Dashmoola Kwath, Erand Taila, Reference: Charak Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: sos, Duration: 1 Days(3) Medicine Name: kebuka Taila, Reference: Database on medicine used in ayurveda volume 7,pg.208, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: sos, Duration: 4 Weeks(4) Medicine Name: Tab Misoprostol, Reference: Modern Medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 0.025(mg), Frequency: sos, Duration: 1 Days
Inclusion Criteria
Age From
21.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
1. Patient with 37th week of gestation with singleton pregnancy and cephalic presentation
2. Height 148 to 172cm
3. Hemoglobin more than or equal to 10gm%
4. Patient with borderline or adequate pelvis
ExclusionCriteria
Details
1. History of previous LSCS
2. Patient having Bad obstetric history, precious pregnancy
3. Pregnancy associated with severe Pregnancy induced hypertension, Pre-eclampsia, Eclampsia, Gestational Diabetes, Placenta previa, Abruptio placentae, severe oligohydramnios, severe polyhydramnios, severe IUGR
4. Patients with Cephalo-pelvic disproportion, malpresentation.
5. Patients suffering with systemic disorders like Diabetes Mellitus, Renal dysfunction, Cardiac disorder, Tuberculosis, Coagulopathies.
6. Patients diagnosed with Benign or Malignant tumor of Reproductive system, Recto vaginal fistula, Vesico-vaginal fistula, second and third degree uterine prolapse
7. History of Fothergill repair, Recto vaginal fistula, Vesico-vaginal fistula
8. VDRL, HIV, HBsAg positive pregnant woman.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Sukhaprasava (Normal Vaginal Delivery)
45 days
Secondary Outcome
Outcome
TimePoints
• Differences in the incidence of complications of all four stages of labor and up to 10 days postpartum between the groups
• Differences in the rate of Sukhaprasava (Eutocia) & Shalyajanana (Caesarean section) between the groups
• Differences in the incidence of fetal distress between the groups
45 days
Target Sample Size
Total Sample Size="60" Sample Size from India="60" 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)
01/07/2024
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="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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
Need of Study:
To decrease the utilization of oxytocic drugs in conduction of normal vaginal delivery.
Protracted cervical dilatation and unripe cervix are the leading causes of fetal distress and prolonged labor. Yoni Pichu application during 9th month brings optimum effacement and ripening of cervix as it causes hydration of tissues and remodeling of cervix.
Basti and Yoni Pichu increases uterine tone and avoid atonic PPH and reduce the rate of obstetric hysterectomy due to PPH.
Null Hypothesis: There is no difference between Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Alternate hypothesis: There is difference between Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Research Question: Is there any difference between Integrated and Ayurvedic protocol in achieving Sukhaprasava?
Aim: To evaluate and compare the efficacy of Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Primary Objective: To evaluate and compare the efficacy of Integrated and Ayurvedic protocol in achieving Sukhaprasava.
Secondary Objective:
To access and compare the incidence of complications of all the four stages of labor and up to 10 days after delivery.
To access and compare the rate of Sukhaprasava (Eutocia) and Shalyajanana (Caesarean section)
To access and compare the incidence of fetal distress.
Drug Intervention:
Two Group
Group MBP- Bala Taila Matra basti, Kebuka Taila Yoni Pichu, Asthapan Basti with Erand Taila and Dashmool Kwath, Tab Misoprostol.
Group BP- Bala Taila Matra basti, Kebuka Taila Yoni Pichu, Asthapan Basti with Erand Taila and Dashmool Kwath.