| CTRI Number |
CTRI/2024/07/069927 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the efficacy of Guduchi ghanvati in pruritus gravidarum(Garbhini kandu) |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Guduchi ghanvati in pruritus gravidarum (Garbhini kandu) |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha Hemant Garibe |
| Designation |
MS scholar |
| Affiliation |
Dr DY Patil college of ayurved and research centre, Pimpri |
| Address |
OPD no.-2 Streerog prasuti tantra, Dr DY Patil college of ayurved and research centre Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7057337784 |
| Fax |
|
| Email |
garibesneha98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smritika Taware |
| Designation |
MD professor |
| Affiliation |
Dr DY Patil college of ayurved and research centre, Pimpri |
| Address |
OPD no.-2 Streerog prasuti tantra, Dr DY Patil college of ayurved and research centre Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9850967067 |
| Fax |
|
| Email |
bhonsalesmritika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Hemant Garibe |
| Designation |
MS scholar |
| Affiliation |
Dr DY Patil college of ayurved and research centre, Pimpri |
| Address |
OPD no.-2 Streerog prasuti tantra, Dr DY Patil college of ayurved and research centre Pimpri, Pune, Maharashtra
MAHARASHTRA
411018
India |
| Phone |
7057337784 |
| Fax |
|
| Email |
garibesneha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil college of ayurved and research Centre pimpri pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Hemant Garibe |
| Address |
Dr DY Patil college of ayurved and research centre, Pimpri, Pune , Maharashtra -41108 |
| 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 Sneha Garibe |
Dr. D. Y. Patil college of ayurved and research Centre pimpri pune |
Opd and ipd streerog evam prasutitantra department Dr. D. Y. Patil college of ayurved and research Centre pimpri pune
Pune
MAHARASHTRA |
7057337784
garibesneha98@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:O266||Liver and biliary tract disordersin pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: guduchighanvati, Reference: bhavprakash nighantu guduchyadivarg, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Garbhini suffering from symptom of itching over the body of varying intensity maybe primigravida or multigravida. |
|
| ExclusionCriteria |
| Details |
Pruritus with rash, seropositive patients, pre-existing gallbladder or liver diseases, autoimmune diseases, diagnosed with jaundice, pre-existing skin diseases and fungal infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Guduchi ghanvati in pruritus gravidarum(Garbhini kandu)which will be assessed by verbal rating scale. |
15 days study with follow up on 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of guduchi ghanvati |
15 days study with follow up on 7th and 15th day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/07/2024 |
| 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="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 to evaluate the efficacy of guduchi ghanvati in pruritus gravidarum. Total 45 patients will be enrolled and guduchi ghanvati of 250 mg will be given twice a day after meals with lukewarm water. The final conclusion will be drawn on the basis of statistical methods. |