| CTRI Number |
CTRI/2025/04/084874 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Efficacy of Dys-Fizz Tablet and Hinguvachadi Churna in Managing Udavartini Yonivyapad |
|
Scientific Title of Study
|
A randomized controlled clinical study to compare the efficacy of dys-fizz tablet with hinguvachadi churna in the management of udavartini yonivyapad |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Shingare |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujrat India Pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8408075710 |
| Fax |
|
| Email |
shingaredivya9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abha L Ravi |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujrat India Pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8281578252 |
| Fax |
|
| Email |
abharavi22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Shingare |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Department of Prasuti Tantra Evum Stree Roga, Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujrat India Pincode-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8408075710 |
| Fax |
|
| Email |
shingaredivya9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Divya Shingare Post Graduate Scholar Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujrat India Pincode-391760 |
|
|
Primary Sponsor
|
| Name |
Dr Divya Shingare |
| Address |
Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujrat India Pincode-391760 |
| 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 Divya Shingare |
Khemdas Hospital |
OPD No. 05 Department of Prasuti Tantra Evum Stree Roga Ground Floor Khemdas Hospital Parul Institute of Ayurved and Research Parul University P.O Limda Vadodara Gujrat India Pincode-391760
Vadodara
GUJARAT |
8408075710
shingaredivya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DYS-FIZZ TABLET, Reference: Ashtang Hridaya Chikitsa 14/31-33, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -Efficacy of DYS-fizz tablet in the management of Udavartini | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hinguvachadi Choorna, Reference: Ashtang Hridaya Chikitsa 14/31-33, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -Balances vata dosha and alleviate symptoms of Udavartini Yonivyapad, such as irregular menstrual flow and abdominal discomfort. Its carminative, antispasmodic, and digestive properties help in relieving pain and promoting uterine health. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed patients of Udavartini Yonivyapad ( Patients suffering from dysmenorrhea).
Patients suffering from dysmenorrhea for the past 3 or more consecutive cycles.
|
|
| ExclusionCriteria |
| Details |
Age below 18years and above 40 years. Patient coming with chief complaints of painful menstruation with regular.
Females with irregular menstrual cycle.
Patients having congenital anomalies leading to dysmenorrhea.
Patient with IUD /oral contraceptives.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DYS-FIZZ tablet is more effective than hinguvachadi choorna in management of udavartini yonivyapad |
BT- 0th Day
DT- 4th Day of 1st and 2nd cycle of Menstruation
AT- 12th Week
Treatment Duration- 1st 6days of expected munstruation date and 2days of menses for 2cycle
Assesment on 4th Day of menses
Final Assesment on 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hinguvachadi choorna is equal effective as DYS-FIZZ tablet in udavartini yonivyapad |
BT- 0th Day
DT- 4th Day of 1st & 2nd cycle of Menstruation
AT- 12th Week
Treatment Duration- 1st 6days of expected munstruation date & 2days of menses for 2cycle
Assesment on 4th Day of menses
Final Assesment on 12th week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
21/05/2025 |
| 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
|
Dysmenorrhea, or painful menstruation, affects approximately 70.1% of women in India. Understanding this condition is crucial for improving quality of life and daily functioning. While modern medicine offers temporary relief, Ayurveda provides a holistic approach, particularly through the study of Udavartini Yonivyapad, a type of dysmenorrhea linked to imbalanced Vata dosha. Ayurvedic treatments focus on addressing the root cause, such as balancing Vata through dietary changes, lifestyle modifications, and herbal remedies. This study aims to compare the effectiveness of DYS-fizz tablet and Hinguvachadi Churna in managing Udavartini Yonivyapad. The study will involve 80 patients diagnosed with dysmenorrhea, randomly divided into two groups, with each receiving one of the treatments for three months. Outcomes will be assessed using a range of criteria, including pain intensity, working ability, and menstrual symptoms. The research hopes to bridge Ayurvedic and modern treatments, offering more effective, personalized options for dysmenorrhea management. |