| CTRI Number |
CTRI/2023/10/059153 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study of dhanyaka ghrita and Yoda therapy in the management of Primary Dysmenorrhea |
|
Scientific Title of Study
|
A clinical study of Dhanyaka Ghrita and Yoda therapy in the management of Udavartini Yoni vyapad(Primary Dysmenorrhea) |
| 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 Imran Faruque Mondal |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic College Hospital Guwahati 14 |
| Address |
Department Prasuti Tantra Evum Stri Roga Govt Ayurvedic College Hospital
Jalukbari Guwahati 14
Kamrup Assam
Kamrup
ASSAM
781014
India |
| Phone |
8618055868 |
| Fax |
|
| Email |
imranfaruquemondal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKaushalya Khakhlary |
| Designation |
Associate professor |
| Affiliation |
Govt Ayurvedic College Hospital Guwahati 14 |
| Address |
Department Prasuti Tantra Evum Stri Roga Govt Ayurvedic College Hospital
Jalukbari Guwahati 14
Kamrup Assam
Kamrup
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKaushalya Khakhlary |
| Designation |
Associate professor |
| Affiliation |
Govt Ayurvedic College Hospital Guwahati 14 |
| Address |
Department Prasuti Tantra Evum Stri Roga Govt Ayurvedic College Hospital
Jalukbari Guwahati 14
Kamrup Assam
Kamrup
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College Hospital
Jalukbari Guwahati
Kamrup Assam 781014 |
|
|
Primary Sponsor
|
| Name |
Dr Imran Faruque Mondal |
| Address |
Department Prasuti Tantra Evum Stri Roga,Govt Ayurvedic College Hospital
Jalukbari, Guwahati 14
Kamrup,Assm |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kaushalya Khakhlary |
Govt Ayurvedic College Hospital Jalukbari Guwahati assam 781014 |
OPD and IPD of Prasuti Tantra Evum Stree Roga Department Govt Ayurvedic College Hospital Jalukbari Guwahati Assam 781014
Kamrup
ASSAM |
8638787369
drkaushalya01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Govt Ayurvedic College Hospital Jalukbari Guwahati Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dhanyaka ghrita, Reference: vangasen 112-114, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: koushna jala), Additional Information: Along with yoga therapy |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Reproductive Age Group
Patient suffering from pain during menstruation from more than 2 consecutive cycle
Irrespective of gravida |
|
| ExclusionCriteria |
| Details |
Patient with identifiable pelvic pathology nd menstrual irregularities excluding Dysmenorrhea
Patient with history of other medical illness that may interfere with course of treatment
Pregnancy |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pain during menstruation |
Decrease in pain during menstruation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
USG Lower abdomen report to be within normal limit
Blood RE TC DLC BT CT RBS Sr Creatinine
HIV VDRL HBsAg HCV TSH Plt.Count
Urine RE CS should be within normal limit |
90days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/11/2023 |
| 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
|
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 an effectiveness of Dhanyaka Ghrita and yoga therapies in the management of udavartini yoni vyapad (Primary Dysmenorrhea). This is done compulsory part of post graduate course.Total number of patients to be studied is 90 with duration of 90days |