| CTRI Number |
CTRI/2025/07/090102 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Punarnava churna vati in heavy menses in treating Raktapradar |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the efficacy of Punarnava churna vati in the management of Raktapradar with special reference to Menorrhagia |
| 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 Sonal Vijay Jaiswal |
| Designation |
PG Scholar |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik Kamal Nagar Panchvati Nashik 422003 |
| Address |
Dr Sonal Vijay Jaiswal
Department of Prasuti tantra and Strirog
OPD No 4 Ground floor
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik
Kamal Nagar Panchavati Nashik 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9702199601 |
| Fax |
|
| Email |
jaiswalsonal212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Suresh Deshmukh |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Deshmukh niwas Ramwadi Baijabaichi Chhavani Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Suresh Deshmukh |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik |
| Address |
Deshmukh niwas Ramwadi Baijabaichi Chhavani Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9403513983 |
| Fax |
|
| Email |
varshasdeshmukh15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal Nagar Panchavati Nashik 422003 Maharashtra India
Department of Prasuti tantra and Strirog OPD no 4 ground floor |
|
|
Primary Sponsor
|
| Name |
Dr Sonal Vijay Jaiswal |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal Nagar Panchavati Nashik 422003
Department of Prasuti tantra and Strirog OPD no 4 ground floor |
| 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 Sonal Vijay Jaiswal |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi road Nashik |
Department of Prasuti tantra and Strirog
OPD No 4 Ground floor
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Nashik
Kamal Nagar Panchvati Nashik 422003
Nashik
MAHARASHTRA |
9702199601
jaiswalsonal212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamalnagar Hirawadi Panchavati Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: RAKTAYONIROGAH/ASRUJA/APRAJA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Tranexamic acid 500mg | Tranexamic acid is an antifibrinolytic drug that works by stopping the breakdown of blood clots thereby useful in treating and preventing excessive bleeding | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnava churna vati , Reference: Raj nighantu in Parpatadivarga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient having excessive but cyclic menses of more than 7 days
Hemoglobin should be more than 8gm percent
Patient having bleeding in excessive amount that is number of pads used
|
|
| ExclusionCriteria |
| Details |
Non cooperative patient
Hemoglobin less than 8gm percent
Patient with comorbidities like Diabetes mellitus Thyroidism Hypertension
Patient with IUCD inserted
USG showing retained products of conception
Patient with recent history of dilatation and curettage threatened or spontaneous or incomplete abortion within last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Raja Praman Rajastrav avadhi Adhodar shool |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce Strava swaroop generalized weakness Bhrama accompanied with excessive raja strava |
2 menstrual cycles |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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 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
|
Randomized controlled clinical trial to study the efficacy of Punarnava churna vati in the management of Raktapradar with special reference to MenorrhagiaPrimary ObjectiveTo study the efficacy of Punarnava churna vati with jala in Raktapradar with special reference to Menorrhagia Secondary ObjectiveTo study the disease Raktapradar according to Ayurveda and Modern literature of Menorrhagia Literary review regarding Punarnava churna vati To study the efficacy of Punarnava churna vati against Tranexamic acid Material and MethodsPatients will be divided into two groups by simple randomized method as Group A and Group B as trial group and control group respectively wherein Group A will be given Punarnava churna vati with jala of dose vati of 500mg twice a day and Group B will be given Tab Tranexamic acid 500mg dose 1 tablet twice a day and follow up will be done on fifth seventh and tenth day of menses with assessment of lakshanas and clinical assessment will be done for three cycles that is two cycles with medication and third cycle without medication Inclusion criteriaPatients between 18 and 40 years of age Patients having excessive but cyclic menses of more than 7 days Hemoglobin should be more than 8gm percent Patients having bleeding in excessive amount by noting the number of pads used per day Exclusion criteriaNon cooperative patients Hemoglobin less than 8gm percent USG showing retained products of conception and patient having a recent history of dilatation and curettage done or dilatation and evacuation done and history of threatened spontaneous or incomplete abortion within last 3 months Withdrawal criteria Patient leaving the treatment without completing the treatment course If any adverse effects seen during the treatment Any disease taken place during the treatment Assessment criteriaAssessment of the patient will be done on the basis of raja pravritti kala raja praman raja varna generalized weakness assosciated with the ability to do daily routine activities abdominal pain and bodyache during heavy menses along with the consistency of the bloodflow
Patients will be selected as per inclusion and exclusion criteria along with well informed consent form filled by the patients accordingly and data will be collected using case record form and observation will be done in the form of tables and graphs Results and inference will be drawn on the basis of the data obtained before and after treatment using statistical data and method
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