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CTRI Number  CTRI/2025/09/094175 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A clinical study comparing the effects of ksheerabala oil vaginal tampon combined with sukhaprasava ghee enema versus sukhaprasava ghee enema alone during the ninth month of pregnancy on labor outcome. 
Scientific Title of Study   An open label double arm randomised clinical study to compare the efficacy of ksheerabala taila yoni pichu with sukhaprasava ghrita matrabasti and sukhaprasava ghrita matrabasti only in navama masa garbhini paricharya on prasava 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshitha m n 
Designation  Pg scholar 
Affiliation  Sri kalabyaraweshwara ayurvedic medical college hospital adn research centre 
Address  Room number 209 skamch and rc 10 pipeline road vijayanagara 2nd stage hampi nagara rpc layout vijayanagara bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  7899294016  
Fax    
Email  harshithamn1999com@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr papiya jana  
Designation  Professor 
Affiliation  Sri kalabyaraweshwara ayurvedic medical college hospital adn research centre 
Address  Room number 209 skamch and rc 10 pipeline road vijayanagara 2nd stage hampi nagara rpc layout vijayanagara bengaluru

Bangalore
KARNATAKA
560104
India 
Phone  9886716216  
Fax    
Email  drpapiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr papiya jana  
Designation  Professor 
Affiliation  Sri kalabyaraweshwara ayurvedic medical college hospital adn research centre 
Address  Room number 209 skamc and rch 10 pipeline rod vijayanagara 2nd stage hampi nagara rpc layout vijayanagara bengaluru


KARNATAKA
560104
India 
Phone  9886716216  
Fax    
Email  drpapiya@gmail.com  
 
Source of Monetary or Material Support  
nil  
 
Primary Sponsor  
Name  Harshitha m n 
Address  room number 209 department of prasooti tantra and stree roga skamch and rc vijayanagara bengaluru 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr kiran m goud   Sri kalabyraweshwara ayurvedic medical college hospital and research centre   Room No 209 Department of PTSR
Bangalore
KARNATAKA 		 9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri kalabyraweshwara ayurvedic medical college hospital and research centre Vijayanagara Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  grabhini paricharya 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: sukhaprasava ghritha, Reference: arogyakalpadrum, Route: Rectal, Dosage Form: Ghrita, Dose: 75(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: ksheerabala taila, Reference: sahasrayogam taila prakarana, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: sukhaprasava ghritha, Reference: arogyakalpadruma, Route: Rectal, Dosage Form: Ghrita, Dose: 75(ml), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Pregnant women aged between 19 to 35 years
Primi gravida from 37 weeks of gestation onwards as mentioned in diagnostic criteria
Subjects with Vertex presentation
 
 
ExclusionCriteria 
Details  Subjects with High risk pregnancy like pregnancy induced hypertension pre eclampsia eclampsia and placenta previa
Subjects with Multiple pregnancy
Subjects having history of any other systemic illness that may interfere with the course of treatment 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of ksheerabala taila yoni pichu with sukhaprasava ghritha matrabasti and sukhaprasava ghritha matrabsti only in navama masa garbhini paricharya on prasava  At the time of onset of labor pains 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   N/A 
Date of First Enrollment (India)   15/09/2025 
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="5"
Days="5" 
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  

Motherhood often described as the embodiment of unconditional love and nurturing. ayurveda explains garbhini paricharya that helps in maintenance of the doshas in equilibrium and avoid development of risks and complication during pregnancy. These measures help her to prepare physically and psychologically for the swabhavika prasava. prasava kala have been mentioned as starting from the ninth month till the end of eleventh or twelfth month and there are various factors which can influence the normal progress of labour. Hence the importance of ninth month garbhini paricharya has been emphasized in ayurvedic classics which explain the role of prasuta maruta or apana vayu and vyana vayu during labour. Garbha nishkramana kriya1 is one of the vital functions of apana vayu and prasarana-akunchana (contraction and relaxation) of the uterus is controlled by vyana vayu in swabhavika prasava  apana vayu along with vyana vayu controls the onset of regular uterine contractions and hence expulsion of foetus and placenta2 occurs simultaneously. 

          The risks and complications during pregnancy might increase when labour is induced or augmented. However over the past decades the incidence of labour induction for shortening the duration of labour has continued to rise. also the recent data from the national family health survey 2016 and 2017(nfhs 4) reveals that in india the rate of caesarean-sections has doubled over the last decade raising the countrys average caesarean-section rate 17.2% and 21.5% over the same period3.

         Hence there is a requirement to utilize garbhini paricharya for sukha prasava and to reduce various risks factors associated with labour. Acharya vaghbhata has included administration of yoni pichu with madhuroushadhi siddha sneha and anuvasana basti in garbhini as part of garbhini paricharya from the starting of navama masa4-7 till her prasava. here the clinical study will be done using ksheerabala thaila8 yoni pichu and sukhaprasava ghrita9 matrabasti which aims to promote normal functioning of sthanika vata dosha and achieving normal vaginal delivery without undue complications.

 
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