| CTRI Number |
CTRI/2025/03/082354 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of regimen mentioned in Ashtang Sanghraha followed by women after delivery for normal state after delivery. |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE ADD ON EFFECT OF ASTANG SANGHRAHOKTA SUTIKA PARICHARYA IN THE MANAGEMENT OF SUTIKA 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 |
Dr.Komal Prakash Patil |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college postgraduate training and Research centre Kodoli District -kolhapur |
| Address |
Department of Prasutitatra evum Streerog IPD AND OPD NO 8 AND 15 Yashwant ayurvedic college postgraduate training and Research centre Kodoli
District - Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8999219684 |
| Fax |
|
| Email |
patilvidhi111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishala Turlapati |
| Designation |
Guide HOD and Professor |
| Affiliation |
Yashwant ayurvedic college postgraduate training and Research centre Kodoli |
| Address |
Department of Prasutitatra evum Streerog Yashwant ayurvedic college postgraduate training and Research centre Kodoli District kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Komal Prakash Patil |
| Designation |
PG scholar |
| Affiliation |
Yashwant ayurvedic college postgraduate training and Research centre Kodoli District -kolhapur |
| Address |
Department of Prasutitatra evum Streerog IPD and OPD NO 8 Yashwant ayurvedic college postgraduate training and Research centre Kodoli District -kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8999219684 |
| Fax |
|
| Email |
patilvidhi111@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Komal Prakash Patil |
| Address |
Yashwant ayurvedic college postgraduate training and Research centre Kodoli |
| 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 |
| Komal Prakash Patil |
Yashwant ayurvedic college postgraduate training and Research centre Kodoli District kolhapur |
IPD and OPD no 8 and 15 Streerog evum Prasutitatra Yashwant ayurvedic college postgraduate training and Research centre Kodoli District -kolhapur
Kolhapur
MAHARASHTRA |
8999219684
patilvidhi111@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 | Procedure | - | Sutika paricharya | (Procedure Reference: Ashtang Sanghraha Sharir Sthana Adhyaya 3/38, Procedure details: Bala Tail abhyanga (sarvang)-Pratkala.
Goghritapana - After Kshudabodha.
Udar Abhyanga- after goghritapana.
Udar vestana- after udar abhyang.
Yavagupana -after sneha jirna.
Ushnodaka parisheka- before & after sneha & yavagupana.
Yushpana - after 3 days.
Cap.Amoxicillin 500 mg thrice a day with water after food.
Sitz bath once a day.
Betadine dressing on episiotomy wound twice a day.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Drug and procedure | Cap.Amoxicillin 500 mgfor 3 days.
Antacid (sos).
Analgesic(sos).
Bladder care(sos catheterization).
Sitz bath with betadine solution.
Betadine dressing on episiotomy wound
|
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Puerperal women irrespective of caste, parity, income group, and
occupation will be selected.
2.vaginal delivery cases will be selected. |
|
| ExclusionCriteria |
| Details |
1. Women with history of convulsions.
2. Women having severe skin diseases.
3. Women underwent cesarean section |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the add on effect of ashtang sangrahokta sutika paricharya in the
management of sutika W.S.R. to normal puerperium |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the role of ashtang sangrahokta sutika paricharya.
2) To Support health status of mother during puerperal period.
3) To promote Involution of uterus effectively followed by garbhashay
shodhana and vatashamana.
4) To study in detail of sutika awastha and the changes which occures during
this period by both ayurvedic and modern view.
5) To achieve good lactation and ensure overall well being.
6) To achieve the outcome in 45 days.
7) To assess the changes with body weight, length of uterus from symphysis
pubis. |
45 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 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [patilvidhi111@gmail.com].
- For how long will this data be available start date provided 18-03-2025 and end date provided 18-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This is randomized open controlled clinical study to evaluate add on effect of ashtang sangrahokta sutika paricharya in the management of sutika in 100 sutika conducted at opd and ipd of yashwant dharmarth rugnalay Kodoli , kolhapur.The outcome.will be assess after 7 days and 45 days. |