| CTRI Number |
CTRI/2025/05/087009 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| 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
|
A study to see how well gokshuradi guggulu vati in the management of the asrigdarapatients |
|
Scientific Title of Study
|
A randomised control trial in the management of the asrigdara with the goksuradi guggulu vati |
| 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 Swati Sharma |
| Designation |
Pg scholar |
| Affiliation |
sri sai ayurvedic pg medical college and hospital aligarh |
| Address |
Prasuti tantra evum stri rog department sri sai ayurvedic pg medical college and hospital aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8650564243 |
| Fax |
|
| Email |
swatisharma7750@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trilochan Mohanto |
| Designation |
Professor |
| Affiliation |
Sri sai ayurvedic pg medical college and hospital aligarh |
| Address |
Sri sai ayurvedic pg medical college and hospital aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9993304678 |
| Fax |
|
| Email |
tmahanta72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trilochan Mohanto |
| Designation |
Professor |
| Affiliation |
Sri sai ayurvedic pg medical college and hospital aligarh |
| Address |
Sri sai ayurvedic pg medical college and hospital aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9993304678 |
| Fax |
|
| Email |
tmahanta72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri sai ayurvedic pg medical college and hospital,Aligarh Uttar Pradesh 202001 |
|
|
Primary Sponsor
|
| Name |
Dr Swati sharma |
| Address |
Sri sai ayurvedic pg medical college and hospital aligarh |
| 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 Swati Sharma |
Prasuti tantra evam stri rog department Sri sai ayurvedic pg medical college and hospital aligarh |
Opposite phal mandi sarsol aligarh 202001
Aligarh
UTTAR PRADESH |
8650564243
swatisharma7750@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe sri sai ayurvedic pg medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N926||Irregular menstruation, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: goksuradi guggulu vati, Reference: yogratnakar prameha chikitsa , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 2 Months, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Raktatambhak yoga , Reference: Yogratnakar , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 2 Months, anupAna/sahapAna: Yes(details: -madhu), Additional Information: Patient will be adviced to take 2 tablets both times in a day |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient suffering from asrigdara with excessive bleeding. |
|
| ExclusionCriteria |
| Details |
Patient who are suffering from polyp erosion carcinoma menopausal bleeding with coagulation disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study will be effective for patient in the management of asrigdara |
Primary outcome will be assessed after 2 months of medicine intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical research can be used for making line of treatment for asrigdara |
Secondary outcome will be assessed after one year of clinical trails on patients of ashrigdara |
|
|
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 1 |
|
Date of First Enrollment (India)
|
05/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 random clinical study is based on gynecological problem related to abnormal uterine bleeding correlated with ayurvedic term ashrigdara. This study will be comparetive with 30 patient who were suffering from asrigdara will be treated with gokshuradi guggulu vati and 30 patient with raktstambhak yoga for 2 months after that we will compare the both the groups for medicine effectiveness. |