| CTRI Number |
CTRI/2024/11/077179 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of chatrujat yavagu in normal puerperium |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE ADD ON EFFECT OF CHATURJATA YAVAGU IN SUTIKA AWASTHA W.S.R. TO NORMAL PUERPERIUM. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ingole Mira Shankar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic medical college PFT and RC kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli striroga and prasutitantra department,OPS no8,15 and IPD 26 ,kodoli dist kolhapur.MAHARASHTRA
Yashwant Ayurvedic Medical College PGT and RC kodoli striroga and prasutitantra department,OPS no8,15 and IPD 26 ,kodoli dist kolhapur.MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020154901 |
| Fax |
|
| Email |
ingolemira40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ingole Mira Shankar |
| Designation |
Pre MS. Prasuti Tantra and Stree Roga scholar |
| Affiliation |
|
| Address |
Opd no 8 and ipd no 26 yashavant ayurvedic College post graduate training centre and research center kodoli td panhala dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7020154901 |
| Fax |
|
| Email |
ingolemira40@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Chandrashekhar Mule |
| Designation |
Associate professor in stree roga and Prasuti Tantra department |
| Affiliation |
Yashwant ayurvedic College Kodoli kolhapur |
| Address |
Yashvant ayurvedic College post graduate training centre and research center kodoli td panhala dist kolhapur
Yashvant ayurvedic College post graduate training centre and research center kodoli td panhala dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
kvt126@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College post graduate training centre kodoli kolhapur |
|
|
Primary Sponsor
|
| Name |
Ingole Mira Shankar |
| Address |
Yashvant ayurvedic College post graduate training centre kodoli kolhapur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ingole Mira Shankar |
Yashwant Ayurvedic Medical College post graduate training research center kodoli |
Stree rog prasutitantra department OPD no8,15 and ipd 26 near by hospital
Kolhapur
MAHARASHTRA |
7020154901
ingolemira40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:O908||Other complications of the puerperium, not elsewhere classified. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chaturjata yavagu , Reference: Harit sahita trutiyasthan , Route: Oral, Dosage Form: Dravaka, Dose: 300(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab cefixime Tab Iron Tab Calcium | Tab cefixime 200 mg Bid 5 days
Tab Iron 60 mg OD 3 month
Tab Calcium 1 gm Od with water for 3 month |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) puerperal women irrespective of cast , parity, income group and occupation.
2) normal vaginal delivery cases .
3) women with preterm labour.
4) puerperal hypertension and gestational hypertension, Gdm |
|
| ExclusionCriteria |
| Details |
Women undergone Caesarean section |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the efficacy of chaturjata YAVAGU and implication in routine post natalcare . |
To achieve the outcome in
7 day
F/u 15 th day
F/u 30 th day
F/U 45 th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the chaturjata YAVAGU in respect to pain involution of uterus, lactation and appetite.
2) support health status of mother during puerperal period
3) study details of awastha and the changes which occur during this period by both ayurvedic and allopathic view. |
To achieve the outcome of study in 7 days. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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
|
Ayurveda in Sutika paricharya they mentioned Garbhashay shodhan vatashaman dipan pachan and balya aushadhi are basic principles of Sutika awastha . Chaturjata yavagu has been given to Sutika which does vatanuloma tarapn deepan shodhan of Garbhashay. Hence due to chaturjata yavagu properties the topic is selected . And because of katu rasa which work as bhedan of sanghatan that help in excretion of rakta dhatu collected inside the uterus and due to kashay Guna shodha of Garbhashay will occur contain pachan and deepan properties which help to metabolize dushti dhatu and excreted in form of lochia . |