| CTRI Number |
CTRI/2026/03/106587 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Raktapradara through Neelotpal ghrit and Mudgadya Ghrit |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Neelotpal Ghrit and Mudgadya Ghrit in the Management of Raktapradara W.S.R. 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 kalpana sen |
| Designation |
MS Scholar ,Department of PTSR |
| Affiliation |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.) |
| Address |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.)
Jaunpur
UTTAR PRADESH
281401
India |
| Phone |
9118957915 |
| Fax |
|
| Email |
ksen0028@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika goel |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.) |
| Address |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.)
Jaunpur
UTTAR PRADESH
281401
India |
| Phone |
9991484933 |
| Fax |
|
| Email |
monikagoyal.goel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika goel |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.) |
| Address |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.)
Jaunpur
UTTAR PRADESH
281401
India |
| Phone |
9991484933 |
| Fax |
|
| Email |
monikagoyal.goel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantari Ayurvedic Medical College and Research Centre Mathura UP |
|
|
Primary Sponsor
|
| Name |
Shri Dhanwantri Ayurvedic Medical College and Research Centre Mathura |
| Address |
Department of PTSR Shri Dhanwantari Ayurvedic Medical College and Research Centre Mathura,281001 U.P. India |
| 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 kalpana sen |
Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.) |
Department of PTSR Shri Dhanwantri ayurvedic Medical College and Research Centre,Mathura (U.P.)
Mathura
UTTAR PRADESH |
09118957915
ksen0028@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICE Shri Dhanwantri Ayurvedic Medical College and Research Centre,Mathura |
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: RAKTATIPRAVRUTTIH, (2) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MUDGADYA GHRITA , Reference: Chakradutta samhita athashragdharadhikar shlok no.19, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NEELOUTPAL GHRITA , Reference: Chakradutta samhita asthayonivyapadhikara shlok 56-57, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female of Age-20 years to 45 years.
2. Females present with chief complaints of raktpradar during rajsrav
3.patients having regular menstrual cycle.
4. Patient ready to participate in study with proper written consent.
5. Patient irrespective of religion, caste, parity and socio-economic occupation will be included. |
|
| ExclusionCriteria |
| Details |
1. Patient age below 20years and above 45years.
2. Patient on hormonal therapy or using IUCDOC pills
3. Disease related to uro-genital system except menorrhagia.
4. Patient having uterine pathologies not causing menorrhagia.
5. patients having irregular menstrual cycle. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Raktapradar symptoms. |
Changes in Raktaprada symptoms in 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant changes in menorrhagia symptoms and also any adverse events experienced by participants. |
2 month. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2026 |
| 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="2"
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
|
Objective : To comparative clinical study to evaluate the efficacy of NEELOUTPAL GHRITA and MUDGADYA GHRITA in the management of Raktapradara W.S.R. Menorrhagia. Participants : Total 50 patients diagnosed with Raktapradara fullfilling the inclusion criteria OPD and IPD of Department of PTSR of Shri Dhanwantari Ayurvedic Medical College and Research centre,Mathura. Interventions; Group A- 25 patients will be treated by the application of NEELOUTPAL GHRITA . Group B-25 patients will be treated by the application of MUDGADYA GHRITA . Primary outcome- changes in Raktapradara symptoms. Secondary outcome-changes in flow ,pain. Adverse effect . follow up -7 days . Time period -3 month. Data Analysis :Data will be analyzed using appropriate statistical methods to compare the effectiveness of the interventions on the primary and secondary outcome. Ethical consideration: The study will be concluded in accordance with ethical guidelines and with informed consent from participants. |