| CTRI Number |
CTRI/2023/02/049834 [Registered on: 17/02/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study The Effect of Lodhradi Kwath In GarbhashayaRhas (Involution Of Uterus) In Sutika Awastha (Puerperium) |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Lodhradi Kwath In GarbhashayaRhas (Involution Of Uterus) In Sutika Awastha (Puerperium) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetika |
| Designation |
MS Scholar |
| Affiliation |
Dr. D. Y. Patil college of Ayurved and Research Centre |
| Address |
Opd no 2 , Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8728950345 |
| Fax |
|
| Email |
doc.geetikaghai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Patil |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr. D. Y. Patil college of Ayurved and Research Centre |
| Address |
Opd no 2, Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Patil |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr. D. Y. Patil college of Ayurved and Research Centre |
| Address |
Opd no 2, Stree roga and Prasuti tantra department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Geetika |
| Address |
Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
| 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 Geetika |
Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
OPD & IPD, Stri roga avum Prasuti Tantra Department, Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
8728950345
doc.geetikaghai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhradi Kwath, Reference: harita samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
mother from 1-42 days after delivery of any mode(normal delivery with or without episiotomy incision, LSCS).
primigravida and multiparas with age of 21 to 35 years.
written informed consent & voluntarily willing patients.
|
|
| ExclusionCriteria |
| Details |
patients having history of post partum hemorrhage or any hemolytic disorder or currently suffering from any type of bleeding disease, trauma, or any other malignancy.
high risk pregnancies.
patient with puerperial complications such as puerperal pyrexia, puerperal sepsis. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Lodhradi Kwath in GarbhashayaRhas (involution of uterus) which will be assessed metrically by measuring the symphysio fundal height in Sutika Awastha (puerperium) |
In normal delivery- 12 days study with follow up on 2nd, 4th and 12th day.
In LSCS- 15 days study with follow up 5th, 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of Lodhradi Kwath, if any |
In normal delivery- 12 days study with follow up on 2nd, 4th and 12th day.
In LSCS- 15 days study with follow up 5th, 7th and 15th day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
04/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THIS IS A SINGLE ARM CLINICAL STUDY .THE AIM OF THE STUDY IS TO EVALUATE THE EFFICACY OF LODHRADI KWATH IN GARBHASHAYARHAS ( INVOLUTION OF UTERUS ) IN SUTIKA AWASTHA (PUERPERIUM). TOTAL 40 PATIENTS WILL BE ENROLLED AND 20 ML LODHRADI KWATH WILL BE GIVEN TWICE A DAY AFTER MEAL .THE AGE GROUP TAKEN FOR THE STUDY IS 21 TO 35 YEARS PUERPERAL WOMEN. |