| CTRI Number |
CTRI/2024/11/076238 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Hinguvachadi tablet and tablet Mefanamic acid and Dicylomine in the management of painful menstruation. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the Efficacy of Hinguvachadi gutika and tablet Mefanamic acid and Dicylomine in the management of Kashtaarthva. |
| 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 Mayur Pratapsing Ingale |
| Designation |
MS Scholar Streerog and Prasutitantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9850147728 |
| Fax |
|
| Email |
mayuringale1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Garudkar |
| Designation |
Associate Professor Streerog and Prasutitantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9422001871 |
| Fax |
|
| Email |
drrahulgarudkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayur Pratapsing Ingale |
| Designation |
MS Scholar Streerog and Prasutitantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9850147728 |
| Fax |
|
| Email |
mayuringale1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Department of Streerog and Prasutitantra Tilak Ayurveda Mahavidyalayam 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 Mayur Pratapsingh Ingale |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Streerog and Prasutitantra department, 1st floor Tilak Ayurved Mahavidyalaya 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA |
09850147728
mayuringale1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N710||Acute inflammatory disease of uterus. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Mefenamic acid and Dicyclomine | Meftal spas stick to the prostaglandin synthesis inhibitor (PGSI) namely COX1 and COX 2
receptor which prohibits the synthesis of prostaglandin . | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hingu-vachadi gutika, Reference: Ashtang Hridyay Chikitsasthan 14/31-33, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All the women unmarried or married complaining of painfull menstruration at least 3 consecutive cycle |
|
| ExclusionCriteria |
| Details |
1) Known Cases of secondary dysmenorrhea with pelvic pathology prolapse ,uterine
fibroid, pelvic endometriosis, cervical stenosis ,Pelvic inflammatory Diseases.
2) Participant with intrauterine contraceptive device
3) Participant is on hormonal therapy. |
|
|
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 pain, duration and intensity |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain, duration, clots and intensity |
5 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
18/11/2024 |
| 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 HIngu-vachadi Gutika and tab Mefanamic acid and Dicylomine 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 |