| CTRI Number |
CTRI/2024/07/071469 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Brahmdandi ( Tricholepis glaberrima, rasanjan and mishri in menorrhagia |
|
Scientific Title of Study
|
Pharmacotherapeutic and Pahrmacognostical Study of Brahmdandyadi yoga in the management of Raktapradara (Menorrhagia) |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nikita panwar |
| Designation |
Ph.D scholar and assistant professor |
| Affiliation |
PGIA, DSRRAU, Jodhpur |
| Address |
PG Department of Dravyaguna Vigyan, PGIA, DSRRAU, Nagaur Road, Karwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784617992 |
| Fax |
|
| Email |
ranusingh936@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Chandan |
| Designation |
Professor and HOD |
| Affiliation |
PGIA, DSRRAU, Jodhpur |
| Address |
Room number 13, PG Department of Dravyaguna Vigyan, PGIA, DSRRAU, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784617992 |
| Fax |
|
| Email |
chandan_singh4@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita panwar |
| Designation |
PhD scholar and Assistant professor |
| Affiliation |
PGIA, DSRRAU, Jodhpur |
| Address |
Room number 8, PG Department of Dravyaguna Vigyan, PGIA, DSRRAU, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784617992 |
| Fax |
|
| Email |
ranusingh936@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Nagaur Road, Karwad, Jodhpur, Rajasthan. India. Pin code 342037 |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Post Graduate Institue of Ayurved, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur road, Karwad, Jodhpur, Rajasthan, India. Pin code 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Chandan Singh |
PGIA, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur road, Karwad, Jodhpur, Rajasthan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikita Panwar |
Sanjeevani Ayurved Hospital |
Sanjeevani Ayurved Hospital, Dravyaguna OPD, Room number 10, DSRRAU Nagaur road karwad jodhpur.
Jodhpur
RAJASTHAN |
9784617992
ranusingh936@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, PGIA, DSRRAU, Jodhpur |
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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmdandyadi Yog, Reference: Siddh Bhaishajya Mani Mala,asrigdara chikitsa, shloka no. 5,6. page no. 338 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Well diagnosed and confirm patient of Raktapradara.
2. Patients aged between menarche and menopause of life and willing to participate in trial.
3. Excessive per vaginal bleeding for more than 2 consecutive cycles.
4. Patients suffering from PCOD. |
|
| ExclusionCriteria |
| Details |
1. Patients having bleeding from carcinoma or big fibroid like conditions.
2. Patients having bleeding due to abortion.
3. Patients having bleeding from sites other than uterus.
4. Patient having coagulation disorders.
5. Patients using IUCDs.
6. Patient having diabetes, thyroid dysfunction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in bleeding through number of used pads per day during menstruation |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pharmacognostical and phytochemical study of drug |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/08/2024 |
| 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 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
|
Menorrhagia is a condition characterized by abnormally heavy menstrual bleeding. Clinical studies on menorrhagia aim to understand its causes, evaluate potential treatments, and improve the overall management of the condition.If left untreated, it can lead to complications such as anemia, weakness, and other serious health issues caused by excessive bleeding. so this study has been planned to evaluate the role of herbal medicines in management of menorrhagia. It is a single arm open labelled interventional study for management of menorrhagia through herbal preparation Brahmdandyadi Yog ( Brahmdandi - Tricholepis glaberrima, Rasanjan - Extract of Berberis aristata and mishri) to evaluate its efficacy. sample size is 100 and trial will be done for three months. |