| CTRI Number |
CTRI/2024/08/072148 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on Bhoomyamlaki Churna and Chandana Churna in the management of Asrigdara w.s.r to menorrhagia and metrorrhagia |
|
Scientific Title of Study
|
A Comparative clinical study on the efficacy of Bhoomyamlaki Churna and Chandana Churna in the management of Asrigdara w.s.r to Menorrhagia and Metrorrhagia |
| 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 Yashi Joshi |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7747817031 |
| Fax |
|
| Email |
yashijoshi03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Ray |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8319356714 |
| Fax |
|
| Email |
sucheta.ray1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sucheta Ray |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
8319356714 |
| Fax |
|
| Email |
sucheta.ray1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar ayurvedic medical college hospital and research centre bhopal MP 462042 |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre 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 Yashi Joshi |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
Department of Prasuti
tantra evum Stri roga
third floor room number
1 Hinotiya alam Kolar
road Bhopal
Bhopal
MADHYA PRADESH |
7747817031
yashijoshi03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mansarovar Ayurvedic College hospital and Research Centre Institutional Ethics Committee |
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: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chandana, Reference: Charak Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu and tandulodaka), Additional Information: Chandana churna will be given twice a day for 90 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhoomyamlaki, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu and tandulodaka), Additional Information: -Bhoomyamlaki churna will be given twice a day for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
The patients having classical symptoms of Asrigdara as per the classical references will be selected. |
|
| ExclusionCriteria |
| Details |
Patients giving history of recent delivery or abortion.
Patients having infections such as candidiasis, trichomonaliasis or any other form of vulvo-vaginitis and pelvic congestion.
Patients having systemic and other disorders like Diabetes, TB, Hypertension etc. will be excluded from the study.
Patients taking oral contraceptive pills. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of Menstrual Bleeding
Interval between 2 menstrual cycle
Vedana |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
CBC
BT CT
USG |
120 days |
|
|
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)
|
20/08/2024 |
| 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 heavy menstrual bleeding in women of reproductive age is 37.9%. Quality of life (QOL) of women with these disorders is compromised. Asrigdara is the common gynecological problem affecting her day to day activities. This leads to other diseases like anemia etc. Bhoomyamlaki Churna and Chandana Churna formulation has been selected to study the efficacy of both drug in the management of asrigdara. The aim of this study is to establish an cost effective , harmless Ayurvedic medication for the treatment of Asrigdara |