| CTRI Number |
CTRI/2024/03/063445 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of Panchasam Churna and Chaturbeej Churna on Udavarta Yonivyapad with special reference to Dysmenorrhea |
|
Scientific Title of Study
|
A comparative clinical study on Panchasam Churna and Chaturbeej Churna in the management of Udavarta Yonivyapad w.s.r. to Dysmenorrhea |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivangi Singh Parihar |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar ayurvedic medical college hospital and research center |
| Address |
Department of Prasuti tantra evum Stri roga, third floor room number 1 Mansarovar ayurvedic medical college hospital and research center Hinotiya alam Kolar road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7247599534 |
| Fax |
|
| Email |
shivangisngh652@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Varsha Adhav Jadhao |
| Designation |
Professor |
| Affiliation |
Mansarovar ayurvedic medical college hospital and research center |
| Address |
Department of Prasuti tantra evum Stri roga, third floor room number 1, Mansarovar ayurvedic medical college hospital and research center, Hinotiya alam Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9762780280 |
| Fax |
|
| Email |
drvarshapadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
shivangi Singh Parihar |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar ayurvedic medical college hospital and research center |
| Address |
Department of Prasuti tantra evum Stri roga third floor room number 1 Mansarovar ayurvedic medical college hospital and research center Hinotiya alam Kolar road Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7247599534 |
| Fax |
|
| Email |
shivangisngh652@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar ayurvedic medical college hospital and research center |
|
|
Primary Sponsor
|
| Name |
Mansarovar ayurvedic medical college hospital and research center |
| Address |
Department of Prasuti tantra evum Stri roga third floor room number 1 Mansarovar ayurvedic medical college hospital and research center Hinotiya alam Kolar road Bhopal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivangi Singh Parihar |
Mansarovar ayurvedic medical college hospital and research center |
Department of Prasuti tantra evum Stri roga third floor room number 1 Hinotiya alam Kolar road Bhopal
Bhopal
MADHYA PRADESH |
7247599534
shivangisngh652@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mansarovar ayurvedic medical college hospital and research center institutional ethics committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chaturbeej Churna, Reference: Bhavprakash Samhita , Haritkyadi Varg Shlok 88-89, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchsam Churna , Reference: Sharangdhar Samhita Madhyam Khand, Adhyay 6 Shlok 93-94, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient with the chief complaint of Udavarta Yonivyapad and symptoms of Dysmenorrhea |
|
| ExclusionCriteria |
| Details |
Any other known chronic illness diabetes mellitus hypertension uterine fibroid endometriosis adenomyosis malignancies congenital anatomical anomalies etc
known case of given drug allergy syphilis gonorrhea HIV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of Panchasam Churna and Chaturbeej Churna in the management of Udavarta Yonivyapad wsr to dysmenorrhea |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Detail study of Udavarta Yonivyapad & Dysmenorrhea
And study of mode of action of Panchasam Churna & Chaturbeej Churna |
3 months |
|
|
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)
|
15/03/2024 |
| 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="0"
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
prevalence of Dysmenorrhea varies between 16% and 91% in women of reproductive
age, with severe pain in 2%-29% of the women studied. Menstrual pain of
Dysmenorrhea is mostly encountered in gynaecological practice. Menstruating
women suffer from varying degrees of discomfort and pain, particularly many of
them suffer from severe pain in first 3 days. Dysmenorrhea is the common
gynaecological problem among women during their adolescence. The painful
menstruation of significant magnitude when it becomes unbearable and
incapacitate day to day activities. There is no previous work done on Panchasam
Churna in reference to Udavarta Yonivyapad w.s.r to Dysmenorrhea. So the
present study has been selected.
|