| CTRI Number |
CTRI/2025/06/088264 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| 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 Kameshwari Panchal |
| Designation |
Post graduate scholar Department of Prasuti tantra and Stri roga |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur
Rajasthan
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8827212096 |
| Fax |
|
| Email |
kameshwaripanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Pushpalatha |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur
Rajasthan
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413206790 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kameshwari Panchal |
| Designation |
Post graduate scholar Department of Prasuti tantra and Stri roga |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur
Rajasthan
302002
India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8827212096 |
| Fax |
|
| Email |
kameshwaripanchal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India
|
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India
|
| Type of Sponsor |
Research institution |
|
|
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 Kameshwari Panchal |
National institute of Ayurveda |
Department of prasuti tantra and stri rog OPD room number 26 and 27 and ipd of Department of Prasuti tantra and stri roga National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN |
8827212096
kameshwaripanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak sharir 8 /29, Procedure details: Asthapana Basti with Erand taila and Dashmoola kwath 350ml Per rectal during the latent phase of labor, empty stomach (1-2 time) Bala taila Matra basti 60ml per rectal 37th week of gestation onwards, twice a week . afterfood (min 2- max 8 times) KebukaTaila Yoni Pichu (Pichu size 3x3cm 20ml Per-vaginal 37th week of gestation onwards (min 2- max 8), twice a week and during active phase of labor repeated 2 hourly up to full dilatation of cervix )
Tab. Misoprostol Tab. Misoprostol Sublingualduring active phase of labor repeated 2 hourly up to full dilatation of cervix
(Min 1 - max 4 times)
)
(1) Medicine Name: Erand taila and Dashmoola kwath,, Reference: Sushruta sutra 38/71, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: sos, Duration: 1 Days(2) Medicine Name: Bala taila, Reference: Sahasrayoga Tailaprakaran, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: sos, Duration: 4 Weeks | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak sharir 8 /29, Procedure details: Asthapana Basti with Erand taila and Dashmoola kwath 350ml Per rectal during the latent phase of labor, empty stomach
(1-2 time)
Bala taila Matra basti 60ml per rectal 37th week of gestation onwards, twice a week . afterfood
(min 2- max 8 times)
KebukaTaila Yoni Pichu
(Pichu size 3x3cm
20ml Per-vaginal 37th week of gestation onwards (min 2- max 8), twice a week and during active phase of labor repeated 2 hourly up to full dilatation of cervix
)
(1) Medicine Name: Erand taila and Dashmoola kwath, Reference: Sushruta sutra 38/71, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: sos, Duration: 1 Days(2) Medicine Name: Bala taila , Reference: Sahasrayoga Tailaprakaran, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: sos, Duration: 4 Weeks(3) Medicine Name: KebukaTaila, Reference: API Part 1,Volume 5, Route: Vaginal, Dosage Form: Taila, Dose: 20(ml), Frequency: sos, Duration: 4 Weeks | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tab. Misoprostol, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 25(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient with 37th week of gestation with singleton pregnancy & cephalic presentation
Patient between age of 21 to 40 years
Height - 4feet 10inch to 5feet 8inch (148 to 172cm)
Hemoglobin more than or equal to 10gm percentage
Patient with borderline or adequate pelvis
|
|
| ExclusionCriteria |
| Details |
History of previous LSCS
Patient having Bad obstetric history, precious pregnancy
Pregnancy associated with severe Pregnancy induced hypertension, Pre-eclampsia, Eclampsia, Gestational Diabetes, Placenta previa, Abruptio placentae, severe oligohydramnios, severe polyhydramnios, severe IUGR
Patients with Cephalo-pelvic disproportion, malpresentation.
Patients suffering with systemic disorders like Diabetes Mellitus, Renal dysfunction, Cardiac disorder, Tuberculosis, Coagulopathies.
Patients diagnosed with Benign or Malignant tumor of Reproductive system, Recto vaginal fistula, Vesico-vaginal fistula, second and third degree uterine prolapse
History of Fothergill repair, Recto vaginal fistula, Vesico-vaginal fistula
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 |
•Difference in the incidence of complications of all four stages of labor and up to 10 days postpartum between the groups.
•Difference in the rate of Sukhaprasava (Eutocia) & Shalyajanana (Caesarean section) between the groups
•Difference 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)
|
02/12/2025 |
| 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="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 Tala Yoni Pichu. Asthapan Basti with Erand Taila and Dashmool Kwath, Tab Misoprostol
Group BP- Bala Taila Matra basti, Kebuka Talla Yoni Pichu, Asthapan Basti with Erand Taila and Dashmool Kwath.
|