| CTRI Number |
CTRI/2022/06/043498 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
12/06/2022 |
| 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
|
Clinical trial on efficacy of dashmoola kwatha with goghrita in normal purperium |
|
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the add on effect of dashmoola kwatha with gou ghrita in Sutika awastha w.s.r. to normal purperium |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Amar Patil |
| Designation |
First Year PG SCHOLAR (SRPT) |
| Affiliation |
Yashwant Ayurved College Kodoli |
| Address |
SRPT Department Yashwant Ayurvedic college & Hospital kodoli Tal.Panhala Dist.Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
07972871393 |
| Fax |
|
| Email |
radhupatil2442@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Chandrashekhar Mule |
| Designation |
Associate Professor(SRPT)& PhD(Scholar) Yashwant ayurvedic college & hospital kodoli |
| Affiliation |
Yashwant Ayurved College Kodoli |
| Address |
SRPT Department Yashwant Ayurvedic college & Hospital Kodoli.Tal. panhala
Dist.kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277612 |
| Fax |
|
| Email |
kvt126@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Amar Patil |
| Designation |
First Year PG SCHOLAR (SRPT) |
| Affiliation |
Yashwant Ayurved College Kodoli |
| Address |
SRPT DEPARTMENT Yashwant Ayurvedic college & Hospital kodoli Tal.Panhala Dist.Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
07972871393 |
| Fax |
|
| Email |
radhupatil2442@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic hospital kodoli maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Radhika Amar Patil |
| Address |
Yashwant Ayurvedic college &Hospital Kodoli. Tal.Panhala Dist.Kolhapur |
| Type of Sponsor |
Other [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 Radhika Amar Patil |
IPD & OPD Striroga Prasuti Tantra Department |
Opd no 8 srpt dept Yashwant Ayurvedic college & Hospital kodoli Tal.Panhala Dist.Kolhapur
Kolhapur
MAHARASHTRA |
07972871393
radhupatil2442@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z392||Encounter for routine postpartum follow-up, (2) ICD-10 Condition:O868||Other specified puerperal infections. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmoola Kwatha, Reference: Siddha Yoga Sangraha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Cefixime | Cefixime 200 mg BID |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Purperial women irrespective of caste,parity,income group & occupation will be selected
2) Full term Normal Delivery cases will be selected
3) Cases without severe complications, PPH will be selected |
|
| ExclusionCriteria |
| Details |
1)Women undergone ceaserean section
2)Women with Preterm Labour
3) Purperial Hypertension & Gestational Hypertension, GDM
4) Pre eclamptic Toxemia & gross anemia |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish efficacy of dashmoola kwatha with goughrita in sutika paricharya WSR purperium |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To establish the efficacy of dashmoola kwatha with goughrita& its implication in routine post natal care
2.to support health status of mother during purpureal period
3.To prevent post-partum complications.
4.To study in details of sutika awastha & the changes which occur during this period by both ayurvedic & allopathic view.
5.To achieve restoration of dhatus to normal prepregnant state, Achieve good lactation & ensure well being |
6 weeks |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized open controlled clinical trial to evaluate the add on effects of dashmoola kwatha with goughrita in sutika awastha w.s.r. to normal purperium. Study will be carried out in IPD & OPD of Striroga Prasuti Tantra Department of Yashwant Hospital Kodoli |