| CTRI Number |
CTRI/2024/02/062860 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
15/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see the effect of udumbara phala oral and krishnmrittika lepa in patients of Heavy Menstrual Bleeding |
|
Scientific Title of Study
|
Clinical study of Udumbara Phala Churna and Krishnmrittika in the management of Asrigdara (Heavy Menstrual Bleeding) |
| 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 Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
SSH BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Associate Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
SSH BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranuradha369@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Gupta |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
LDH Hostel IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8742071366 |
| Fax |
|
| Email |
meet2megha700@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty Of Ayurveda Institute of Medical Science IMS BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Prasuti Tantra Faculty of Ayurveda institute of medical science |
| Address |
IMS Banaras Hindu University VARANASI |
| 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 MEGHA |
Sir Sunderlal Hospital BHU |
OPD No 24 Prasuti Tantra OPD Department of Prasuti Tantra Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH |
08742071366
8742071366
meet2megha700@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECR/526/Inst/UP/2014/RR-20dt.19.5.2020 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, (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: udumber in asrigdara, Reference: Bhav Prakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhav Prakash, Procedure details: over the lower abdomen below the umbilicus)
(1) Medicine Name: krishnmrittika, Reference: Bhav Prakash, Route: Topical, Dosage Form: Lepa Churna, Dose: 0.5(NA), Frequency: bd, Duration: 45 Days | | 3 | Comparator Arm (Non Ayurveda) | | - | Tranexamic acid | Drug
Medicine Name - Tranexamic acid
Dose - 500mg-1gm
Route - Oral
Time of application - 6 hourly
Total duration with follow-ups - During the phase of bleeding |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients of age group 12 to 45 years. |
|
| ExclusionCriteria |
| Details |
1.Patients of age group below 12 years & above 45 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography of the uterus and adnexa and Endometrial thickness |
60 days with four follow up of 15 days each |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prakriti Pariksha |
45 days before and after trial |
| WHO QOL Brief |
45 days before and after trial |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
25/02/2024 |
| 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="0"
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
|
Heavy menstrual bleeding (HMB) is a common gynecological problem, that affects a major part of the female population. HMB can negatively impact on physical, emotional, and social quality of life and reduce the work capacity of women. In the present scenario, increasing concerns about eco-friendliness and sustainable development. Ficus racemose species belongs to the family Moraceae, which is locally known as ‘gular’, Cluster fig tree, and Indian fig tree. This plant is abundantly found in India. The development of a comprehensive framework for sustainable development is crucial. Cluster Figs are ecological keystone species and are also important for traditional, spiritual food and health uses, which often have accompanying conservation practices. The traditional use and management of cluster fig may offer clues to help and guide the development of National policies for sustainable development.
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