| CTRI Number |
CTRI/2024/07/070411 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika (fissure in ano in pregnancy |
|
Scientific Title of Study
|
Single arm clinical study to evaluate the efficacy of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika fissure in ano in pregnancy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Drshubhangi Dhanraj Sonwane |
| Designation |
M S scholar |
| Affiliation |
Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune |
| Address |
OPD no 2, streeroga evum prasutitantra department Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9975614480 |
| Fax |
|
| Email |
shubhangisonwane25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr smritika Taware |
| Designation |
MD professor |
| Affiliation |
Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune |
| Address |
OPD no 2, streeroga evum prasutitantra department Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850967067 |
| Fax |
|
| Email |
bhonsalesmritika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drshubhangi Dhanraj Sonwane |
| Designation |
M S scholar |
| Affiliation |
Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune |
| Address |
OPD no 2 streeroga evam prasutitantra,Dr.D.Y.Patil ayurvedic medical College and research centre pimpri pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9975614480 |
| Fax |
|
| Email |
shubhangisonwane25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil college of ayurved and research centre pimpri pune 411018 |
|
|
Primary Sponsor
|
| Name |
Drshubhangi Dhanraj Sonwane |
| Address |
OPD no 2, streeroga evum prasutitantra Dr.D.Y.Patil Ayurved medical College and research centre pimpri pune 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 |
| DrShubhangi Sonwane |
Dr.D.Y.Patil college of ayurved and research centre pimpri pune 411018 |
OPD no 2 streeroga evum prasutitantra department Dr.D.Y.Patil college of ayurved and research centre pimpri pune 411018
Pune
MAHARASHTRA |
9975614480
shubhangisonwane25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O268||Other specified pregnancy relatedconditions. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi granules with madhu and sheeta kshira , Reference: Kashaypa samhita garbhini chikitsaadhya 1/2, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu,sheeta kshir), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Garbhini with age group of 19 to 40 years will be selected.
2. Garbhini having atleast 3 symptoms of following:
-severe constipation
- Pain during fecation
-burning sensation at anal region
-Bleeding at anal region
3.Both primigravida or multigravida In 2nd and 3rd trimister |
|
| ExclusionCriteria |
| Details |
1. Patients having any chronic or systemic illness.
3. Patient suffering from acquired or congenital immune deficiency.
4. Patients having intussusceptions.
5. Pt having any other associated diseases like pregnancy induced
diabetes, pregnancy induced hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika (fissure in ano in pregnancy) which will be assessed by the symptoms bleeding during defecation, itching over anal region, severe constipation, burning at anal region |
14 days study with follow up on 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse of shatavaryadi granules with madhu and sheeta kshira |
14days study with follow up on 7th and 14th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2024 |
| 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 - NO
|
|
Brief Summary
|
This is a single arm clinical study. The aim of this study is evaluate the efficacy of shatavaryadi granules with madhu and sheeta kshira in management of garbhini parikartika . Total 40 patients will be enrolled and 10gm shatavaryadi granules will be given with madhu and sheeta kshira twice a day after meal for 15 days. The age group taken for study is 21 to 40 years women. The final conclusion will be drawn on the the basis of statistical methods. |