| CTRI Number |
CTRI/2023/04/051966 [Registered on: 25/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study the effect of Triphala Churna with Gudh for Constipation in Pregnancy. |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the Efficacy of Triphala Churna in Garbhini Malavibandh (Constipation in Pregnancy). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vrushali Rameshwar Tikar |
| Designation |
MS Scholar Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pune |
| Address |
OPD No.2 and IPD Prasuti Tantra Department, Dr. D. Y. Patil
College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7796595318 |
| Fax |
|
| Email |
tikarvrushali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Shirke |
| Designation |
Professor of Prasuti Tantra Evum Stree Roga Department |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pune |
| Address |
OPD No.2 and IPD Prasuti Tantra Department, Dr. D. Y. Patil
College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrushali Rameshwar Tikar |
| Designation |
MS Scholar Prasuti Tantra Evum Stree Roga |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pune |
| Address |
OPD No.2 and IPD Prasuti Tantra Department, Dr. D. Y. Patil
College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri,Pune,Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
7796595318 |
| Fax |
|
| Email |
tikarvrushali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Vrushali Rameshwar Tikar |
| Address |
OPD No.2 and IPD Prasuti Tantra Department, Dr. D. Y. Patil
College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra |
| 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 Vrushali Rameshwar Tikar |
Dr. D. Y. Patil College of Ayurved and Research Centre,Pimpri Pune 18 |
OPD No.2 and IPD Prasuti Tantra Department, Dr. D. Y. Patil
College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra
Pune
MAHARASHTRA |
07796595318
tikarvrushali@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:O996||Diseases of the digestive system complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Triphala Churna with Gudh in Garbhini Malavibandh. |
Medicine Name: Triphala Churna,Route: Oral, Dosage Form: Churna, Dose: 3g, Frequency:bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, Anupana: Gudh
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All primi and multi gravida 13 to 37 weeks having symptoms of malavibandh. |
|
| ExclusionCriteria |
| Details |
1.Associated problems like piles, fistula, rectal prolapse
2.Any obstetric high-risk factor-like threatened abortion, low lying placenta, placenta previa
3.Pregnancy with short cervix, treated with cervical encirclage operation
4.Pregnancy with irritable uterus, threaten preterm contractions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe the efficacy of Triphala Churna in Garbhini Malavibandh. |
Drug given for 7 days
Follow up on 4th and 7th day
Total duration of study 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the other effect of Triphala Churna in other symptoms like Katishul and Adhmana. |
Drug given for 7 days
Follow up on 4th and 7th day
Total duration of study 7 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
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 TRIPHALA CHURNA IN GARBHINI MALAVIBANDHA (CONSTIPATION IN PREGNANCY) IN ALL PRIMI AND MULTI GRAVIDA OF 13 TO 37 WEEKS.TOTAL 40 PATIENTS WILL BE ENROLLED.TRIPHALA CHURNA WITH GUDA WILL BE GIVEN ON 0TH AND 4TH DAY FOR TWICE A DAY. FOLLOW UP WILL BE DONE ON 4TH AND 7TH DAY.THE TOTAL DURATION OF THE CASE STUDY WILL BE 7 DAYS.THE FINAL CONCLUSION WILL BE DRAWN BY STATISTICAL METHODS. |