| CTRI Number |
CTRI/2024/10/076031 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Of Efficacy Of Chaturbeej Churna With Latakaranj Churna In The Management Of Garbhashay Shodhan |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Compare The Efficacy Of Chaturbeej Churna And Latakaranj Churna For Garbhashay Shodhan In Sutikavastha |
| 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 Shivani Pandurang Kale |
| Designation |
MS Scholar Prasutitantra Evum Streerog |
| Affiliation |
Tilak Ayurved Mahavidyalay |
| Address |
Tilak Aayurved Mahavidyala Department of Prasutitantra Evum Streerog 1st floor 583/2 Rasta Peth Pune Maharashtra
Tilak Ayurved Mahavidyala Department of Kayachikitsa OPD 5 1st floor 583/2 Rasta Peth Pune Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
8087313652 |
| Fax |
|
| Email |
shivanikale39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rucha Rahul Ganu |
| Designation |
Associate professor Prasutitantra Evum Streerog |
| Affiliation |
Tilak Ayurved Mahavidyalay |
| Address |
Tilak Ayurved Mahavidyalay Department of Prasutitantra Evum Streerog 1st floor 583/2 Rasta Peth Pune Maharashtra
Tilak Ayurved Mahavidyalay Department of Prasutitantra Evum Streerog 1st floor OPD no 11 , 583/2 Rasta Peth Pune Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9822376936 |
| Fax |
|
| Email |
ganu.rucha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Pandurang Kale |
| Designation |
MS Scholar Prasutitantra Evum Streerog |
| Affiliation |
Tilak Ayurved Mahavidyalay |
| Address |
Tilak Aayurved Mahavidyala Department of Prasutitantra Evum Streerog 1st floor 583/2 Rasta Peth Pune Maharashtra
Tilak Ayurved Mahavidyala Department of Kayachikitsa OPD 5 1st floor 583/2 Rasta Peth Pune Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
8087313652 |
| Fax |
|
| Email |
shivanikale39@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital,580/2,Rasta Peth,Pune. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalay |
| Address |
Tilak Ayurved Mahavidyalay Department Of Prasutitantra Evum Streerog 1st floor 583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 Shivani Pandurang Kale |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurveda Mahavidyalaya Department of Prasutitantra and Streerog OPD 11 1st floor 583/2 Rasta Peth Pune
Pune MAHARASHTRA
Pune
MAHARASHTRA |
8087313652
shivanikale39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chaturbeej Churna, Reference: Bhavprakash Purvakhand, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -Ushnodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Latakaranj Churna, Reference: Bhavprakash Purvakhand, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -Ushnodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All primipara,multipara women will be included |
|
| ExclusionCriteria |
| Details |
High risk pregnancies like severe anaemia,GDM,PIH, Pre-eclampsia, Eclampsia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in fundal height of uterus and yonigat strav |
7th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in uterine consistency |
30th day and 45th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/11/2024 |
| 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
|
The study will be intervened by the treatment of Chaturbeej Churna and Latakaranj Churna to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |