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CTRI Number  CTRI/2024/12/078174 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 05/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of Yashtimadhu Siddha Taila Anuvasana Basti with Yonipichu in 9th month of pregnancy for Sukhprasav (Normal Labour) 
Scientific Title of Study   Randomized Controlled Trial to study the efficacy of Yashtimadhu Siddha Taila Anuvasana Basti with Yonipichu in 9th month of pregnancy for Sukhprasav (Normal 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 Jigisha Hitesh Tanna 
Designation  MS Scholar Prasutitantra and Striroga 
Affiliation  MAM S Sumatibhai Shah Ayurved Mahavidyalaya 
Address  MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra and Striroga Sane Guruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9175680909  
Fax    
Email  jhtanna2016@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandakini Sanjog Ghorpade  
Designation  Head of Department of Prasutitantra and Striroga 
Affiliation  MAM S Sumatibhai Shah Ayurved Mahavidyalaya  
Address  MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra and Striroga Sane Guruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9822007570  
Fax    
Email  mandaghorpade@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Jigisha Hitesh Tanna 
Designation  MS Scholar Prasutitantra and Striroga 
Affiliation  MAM S Sumatibhai Shah Ayurved Mahavidyalaya 
Address  MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 12 Department of Prasutitantra and Striroga Sane Guruji Arogya Kendra Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9175680909  
Fax    
Email  jhtanna2016@gmail.com  
 
Source of Monetary or Material Support  
Department of Prasutitantra and Striroga Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra  
Address  Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 
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 Jigisha Hitesh Tanna  Sane Guruji Arogya Kendra   OPD NO 12 Department of Prasutitantra and Striroga Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA 		 9175680909

jhtanna2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-picu, पिचु (Procedure Reference: Charak Sharirsthana 8/32, Procedure details: 1.Route-Yonipichu kept per vaginally. 2.Kala-Yonipichu will be kept till 4-6 hours or till the urge to void urine (aamutra vega). 3.Matra of Yashtimadhu Siddha Taila required for Yonipichu is 15 ml. 4.Autoclaved Pichu will be used. 5.Garbhini will be given a supine position with flexed knees. 6.Sterile Pichu soaked in Yashtimadhu Siddha Taila will be inserted with the Index finger into vagina in such a way that the thread of the pichu should come out of vagina for easy removal. 7.Yashtimadhu Siddha Taila Yonipichu will be kept in Primipara women from 36th week of pregnancy each time once a day & after every 4 days till delivery.)
(1) Medicine Name: Yashtimadhu Siddha Taila, Reference: Charak Sharirsthana 8/32, Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 4 Weeks
2Intervention ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः Pradhan Karma(Procedure Reference: Charak Sharirsthana 8/32, Procedure details: 1.Route-Yashtimadhu Siddha Taila Anuvasana Basti given per Rectally. 2.Kala-After meal. 3.Matra of Anuvasana Basti is 120ml. Ideal matra of Anuvasana Basti is 120 ml but after 36 weeks of gestation, only 100 ml of Anuvasana Basti can be administered & retained. Hence, 100 ml Yashtimadhu Taila will be required. 4.Garbhini will be given left lateral position. 5.Yashtimadhu Siddha Taila will be filled in syringe & sterile rubber catheter will be attached to it. 6.Tip of rubber catheter is dipped in oil & inserted in anal canal towards direction of spine & then piston of syringe is pressed uniformly & Anuvasana Basti is given. 7.Basti Pratyagam Kala, Matra & Swaroop are to be noted by Garbhini & are informed on next visit. 8.Yashtimadhu Siddha Taila Anuvasana Basti will be given from 36th week of pregnancy onwards each time once a day & after every 4 days till delivery.)
(1) Medicine Name: Yashtimadhu Siddha Taila, Reference: Charak Sharirsthana 8/32, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 4 Weeks
3Comparator Arm (Non Ayurveda)-Control groupRoutine Ante Natal Care given to Primipara women from 36th week of pregnancy till delivery.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1. Primipara women with SLIUF (Single Live Intra Uterine Foetus) with 36 weeks of
gestation.
2. Normal foetal position at term. 
 
ExclusionCriteria 
Details  1. Pregnancy associated with any pre-existing or pregnancy induced systemic diseases like Essential Hypertension, Diabetes Mellitus, Liver related disorders, Kidney related disorders,
Heart related disorders, Asthma, Blood related disorders like Thalassemia, Sickle cell anaemia, GDM (Gestational Diabetes Mellitus), Pre-eclampsia or Eclampsia or associated with any immunocompromised illness.
2. Pregnancy associated with placental abnormalities like Placenta previa, Circumvallate placenta, etc. and foetal anomalies like Hydrocephalus, Polyhydramnios, Oligohydramnios, Mal-presentation of foetus.
3. Pregnancy associated with Reproductive tract abnormalities and pelvic abnormalities. 
 
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 
To evaluate the combined effect of Yashtimadhu Siddha Taila Anuvasana basti with
Yonipichu in Primipara women from 36 weeks of pregnancy till delivery for Sukhprasav
(Normal Labour) 		 Administration of Yashtimadhu Siddha Taila Anuvasana Basti with Yonipichu on each visit and on every 4th day till delivery
Administration will be done in Primipara women from 36th week or on
completion of 35th week of
pregnancy till delivery
Follow up and assessment will be done 
 
Secondary Outcome  
Outcome  TimePoints 
Literature study of Garbhini Paricharya
To look for Adverse effects if any 		 Study will be done using Ayurvedic Granthas & modern texts
Preparation of drugs will be done according to the standard procedure
During the regimen observation will be done for any adverse effects if any 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   16/12/2024 
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 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   This is Randomized Controlled Trial to study the efficacy of Yashtimadhu Siddha Taila Anuvasana
Basti with Yonipichu in 9th month of pregnancy for ‘Sukhprasav’ (Normal Labour). The Primary Objective (Aim) is to evaluate the combined effect of Yashtimadhu Siddha Taila Anuvasana Basti with Yonipichu in Primipara women from 36 weeks of pregnancy till delivery for ‘Sukhprasav’(Normal Labour). Observation will be drawn from the outcome of patients.
 
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