| CTRI Number |
CTRI/2024/03/064729 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Siddharthakadi Basti in Retained products of conception |
|
Scientific Title of Study
|
An Exploratory Study To Evaluate The Effect of Siddharthakadi Basti in Retained Products of Conception |
| 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 AVANIKA GUNJIYAL |
| Designation |
MS SCHOLAR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
4th floor, Department of Prasuti Tantra and Stri roga, All India Institute of Ayurveda, Gautampuri Awas, Sarita Vihar
South
DELHI
110076
India |
| Phone |
7982913430 |
| Fax |
|
| Email |
gunjiyalavanika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MEENAKSHI PANDEY |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
4th floor, Department of Prasuti Tantra and Stri Roga, All India Institute of Ayurveda, Gautampuri Awas, Sarita Vihar
South
DELHI
110076
India |
| Phone |
9984549998 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AVANIKA GUNJIYAL |
| Designation |
MS SCHOLAR |
| Affiliation |
All India Institute of Ayurveda |
| Address |
4th floor, Department of Prasuti Tantra and Stri Roga, All India Institute of Ayurveda, Gautampuri Awas, Sarita Vihar
South
DELHI
110076
India |
| Phone |
7982913430 |
| Fax |
|
| Email |
gunjiyalavanika@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda, Gautampuri Awas, Sarita Vihar, Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
4th floor, Department of Prasuti Tantra and Stri Roga, All India Institute Of Ayurveda, Gautampuri Awas, Sarita Vihar, Delhi |
| 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 |
| Dr AVANIKA GUNJIYAL |
All India Institute of Ayurveda |
OPD No.202, Department of Prasuti Tantra and Stri Roga, All India Institute Of Ayurveda, Gautampuri Awas, Sarita Vihar, Delhi-110076
South
DELHI |
7982913430
gunjiyalavanika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research and Biostatistics, All India Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O73||Retained placenta and membranes, without hemorrhage. Ayurveda Condition: GARBA-VYAPAT, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Rasaratna Samuchaya- Dr. Indra dev Tripathi Adhaya Mudhagarbha chikitsa jarayupatnaartham Siddharthakadi basti pg 297,298p, Procedure details: Siddharthakadi basti (Anuvasana Basti with 120ml of Siddharthakadi Tail and Niruha
Basti with 480ml (approx.) Siddharthakadi Kwatha, for maximum 8 days) The basti may be given as per requirement of expulsion of retained products of conception. So,
the duration of siddharthakadi basti is maximum 8 days, but it could be stopped whenever
retained products of conception completely expelled out during the course of siddharthakadi
anuvasana and niruha basti. so, we can stop or may be continue )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Married Female Patient of age 18-45 years old.
2. Thick irregular endometrium on trans-vaginal sonography suggesting RPOC.
(ICD NO.-O03.4) |
|
| ExclusionCriteria |
| Details |
1. Patients with untreated urogenital infections.
2. Patients suffering from any chronic debilitating disease like diabetes mellitus hypertension,
sexually transmitted disease, hepatitis B.
3. Patients not willing to be included in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expulsion of retained products of conception |
Maximum 8 days of drug intervention
FOLLOW-UP
Patient will be monitored daily during basti and will be advised for repeat ultrasonography
(USG) after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Stops P/V Bleeding
2. Relief in abdominal pain
|
Maximum 8 days of drug intervention
FOLLOW-UP
Patient will be monitored daily during basti and will be advised for repeat ultrasonography
(USG) after treatment. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/05/2024 |
| 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
|
INTRODUCTIONRetained products of conception (RPOC) are a common and treatable complication after delivery or termination of pregnancy. The presence of chorionic villi, indicating the existence of trophoblastic tissue or remnants of the placenta, serves as the key criterion for pathologically diagnosing Retained Products of Conception (RPOC).
This single-arm, open-labeled exploratory study aims to fill this gap by examining the impact of Siddharthakadi basti on RPOC. By delving into the synergistic potential of traditional practices like basti, the study seeks to provide valuable insights into the ayurvedic management of RPOC, potentially offering safer and more effective options for women’s reproductive health.
AIMS AND OBJECTIVES • To understand the etiopathogenesis of Retained products of conception. • To find out the efficacy of Siddharthakadi basti in the effect of Retained products of conception. • PRIMARY OBJECTIVE: Expulsion of retained products of conception. • SECONDARY OBJECTIVE: 1. Stops p/v bleeding 2. Relief in abdominal pain
METHODOLOGY MATERIALS AND METHODS â– Step-1: Conceptual study - The detailed study of Retained products of conception will be carried out. â– Step-2: A detailed review of the drug will be done. â– Step-3: Therapeutic intervention.
Study Type-Exploratory Study Study Design- A single-arm open-labeled exploratory study Study Setting- The OPD and IPD of AIIA Sample Size 30 Description- siddharthakadi Kwatha 480ml and siddharthakadi Tail 120ml Duration of treatment-For maximum 8 days FOLLOW-UP: -Patient will be monitored daily during basti and will be advised for repeat ultrasonography (USG) after treatment. |