| CTRI Number |
CTRI/2025/12/099896 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the effect of Bala oil and Yashtimadhu oil therapy on the progress of normal labour in pregnant women |
|
Scientific Title of Study
|
A Comparative Clinical study of the efficacy of Balataila and Yashtimadhu Matrabasti with Yonipichu in Sukhprasava |
| 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 Ratnika Tiwari |
| Designation |
PG scholar Prasuti tantra evam Stree roga |
| Affiliation |
Rani dullaiya smriti ayurveda college and hospital Bhopal |
| Address |
PG department of Prasuti Tantra evam Stree Roga OPD no. 8,Rani dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan, Bhopal Madhya Pradesh 462044 India
Pragati parisar,nehru nagar Bhopal M.P.
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8770235503 |
| Fax |
|
| Email |
tiwariratnika1208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reetu Pandey |
| Designation |
Associate professor Department of Prasuti Tantra evam Stree roga |
| Affiliation |
Rani dullaiya smriti ayurveda college and hospital Bhopal |
| Address |
PG department of Prasuti Tantra evam Stree Roga OPD no. 8,Rani dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan, Bhopal Madhya Pradesh 462044 India
PG department of Prasuti Tantra evam Stree Roga OPD no. 8,Rani dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan, Bhopal Madhya Pradesh 462044 India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9805150593 |
| Fax |
|
| Email |
Vdreetupandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reetu Pandey |
| Designation |
Associate professor Department of Prasuti Tantra evam Stree roga |
| Affiliation |
Rani dullaiya smriti ayurveda college and hospital Bhopal |
| Address |
PG department of Prasuti Tantra evam Stree Roga OPD no. 8,Rani dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan, Bhopal Madhya Pradesh 462044 India
PG department of Prasuti Tantra evam Stree Roga OPD no. 8,Rani dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan, Bhopal Madhya Pradesh 462044 India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9805150593 |
| Fax |
|
| Email |
Vdreetupandey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan,Bhopal Madhya Pradesh 462044 India |
|
|
Primary Sponsor
|
| Name |
Dr Ratnika Tiwari |
| Address |
PG scholar,Rani Dullaiya smriti ayurveda PG college and hospital,Barkhedi kalan, Bhopal Madhya Pradesh 462044 India |
| Type of Sponsor |
Other [self] |
|
|
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 Ratnika Tiwari |
Rani dullaiya smriti Ayurved Hospital Bhopal |
PG department of prasuti tantra evam stree roga OPD no. 8, Rani dullaiya smriti ayurveda PG college and hospital, Barkhedi kalan, Bhopal Madhya Pradesh 462044 India
Bhopal
MADHYA PRADESH |
8770235503
tiwariratnika1208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical comittee,, Rani dullaiya smriti ayurveda PG college and hospital, Barkhedi kalan, Bhopal Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sukhprasava |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu taila, Reference: charak samhita sharir sthana 8/32, vimana sthana 8/139, Route: Vaginal, Dosage Form: Taila, Dose: 60(ml), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Yashtimadhu taila matrabasti 60ml alongwith yonipichu 15ml soaked will be given once a week after 36 weeks of gestation and twice a week after 38 weeks till the onset of labour. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bala taila, Reference: charak samhita sharir sthana 8/32, vimana sthana 8/139, Route: Vaginal, Dosage Form: Taila, Dose: 60(ml), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -Bala taila matrabasti 60ml alongwith yonipichu 15ml soaked will be given once a week after 36 weeks of gestation and twice a week after 38 weeks till the onset of labour. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
pregnant women with normal fetal position at term,having vertex presentation,adequate pelvis and borderline pelvis.
patient having prior caesarean section due to cervical dystocia,failture of induction or due to fetal distress,or breech presentation.
pregnant women with routine ANC profile done. |
|
| ExclusionCriteria |
| Details |
pregnant women having contracted pelvis,mal-presentation,whose ANC and routine hematological,urine examinations and USG are not priorly done.
patients with HIV,HbsAg,VDRL and hepatitis C positive, APH, pre-eclampsia,patients with systemic disorders,bad obstetrics history,multiple pregnancy,malignancy of genital tract. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Bala Taila and Yashtimadhu Taila matrabasti and yonipichu on the progress of labour,increasing the chances of sukhprasava or normal vaginal delivery |
onset of active labour-O hours, 4hours, 8hours, 12hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of each stage of labour,progresss of labour(partograph),pain during labour,reduce labour complications,mode of delivery |
onset of labour,during active labour,at full cervical dilatation,at delivery of baby & placenta,within 1 hour after delivery. |
|
|
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)
|
10/01/2026 |
| 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="0"
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
|
In India,the quantity of caesarean section has dramatically increase in the last few decades.Also the data from Nutritional family health survey reveals that in India the rate of caesarean sections has doubled over the last decades. With the rising incidence of elderly primigravida, the operative intervention practises also increases because of increase in abnormalities during labour. The incidence of labour induction has also incresed due to failture of spontaneous onset of labour at term,or to shorten the duration of labour according to conveinience of the healthcare worker . but there are potential risks assosiated with the procedure. The intervention affects the natural process of labour and maybe assosiated with increased risks of complications especially bleeding, C-section,uterine hyper stimulation,rupture and other adverse outcomes.Safer ways to ease and facilitate the process of labour are therefore warranted. Labor is very painful and delicate process,so any decrement in terms of its duration is very useful to prevent stress to mother and fetus.In Ayurvedic literature, many drugs and procedure are mentioned for Sukhprasava as part of Garbhini Paricharya.Among them, the role of Matrabasti and Yoni pichu is evaluated for its possible role in Sukhprasava,during 9th month helps to ease and augment the labor process and also avoid risk of prolonged and obstructed labour. Subjective criteria include-onset of labour,partogram,type of delivery and bishop’s score. Objective criteria include-frequency/No. of contractions,duration of contractions. |