| CTRI Number |
CTRI/2025/03/083321 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
single arm open label clinical study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating The Impact Of Pradar Nashak Yoga On Quality Of Life In Women With Abnormal Uterine Bleeding. |
|
Scientific Title of Study
|
Clinical Study To Evaluate The Effect Of Pradar Nashak Yoga In Pittaja Asrugdar (AUB-O). |
| 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 Sudha Gupta |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
| Address |
Department of Prasuti Tantra Evam Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Centre Gangoh Saharanpur
Saharanpur UTTAR PRADESH 247341 India |
| Phone |
9568512088 |
| Fax |
|
| Email |
sudhagupta1920@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
dr Venkata Suresh Krishna T |
| Designation |
Associate Professor Department of Prasuti Tantra Evam Stree Roga |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
| Address |
Department of Prasuti Tantra Evam Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Centre Gangoh Saharanpur
Saharanpur UTTAR PRADESH 247341 India |
| Phone |
7411483057 |
| Fax |
|
| Email |
drtvskrishna@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
dr Venkata Suresh Krishna T |
| Designation |
Associate Professor Department of Prasuti Tantra Evam Stree Roga |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre |
| Address |
Department of Prasuti Tantra Evam Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Centre Gangoh Saharanpur
UTTAR PRADESH 247341 India |
| Phone |
7411483057 |
| Fax |
|
| Email |
drtvskrishna@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sudha Gupta |
| Address |
Kunwar Shekhar Vijendra Ayurved
Medical College and Research Centre Gangoh Saharanpur
|
| 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 Sudha Gupta |
Kunwar Shekhar Vijendra Ayurved Hospital and Research Centre Gangoh. |
Room Number 2
Department of Prasuti Tantra Evam Stree Roga
Kunwar Shekhar Vijendra Ayurved
Hospital and Research Centre Gangoh Saharanpur Saharanpur UTTAR PRADESH |
09568512088
sudhagupta1920@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Gangoh Saharanpur-247341 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N70-N77||Inflammatory diseases of female pelvic organs. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Duration of bleeding more than 7 days
2.Amount of blood loss more than 80 ml of menstrual bleeding. |
|
| ExclusionCriteria |
| Details |
1.Age less than 20 years and above 50 years.
2.Hb less than 8 gm per dl.
3.Patient diagnosed with diabetes hypertension thyroid tuberculosis human immunodeficiency virus.
4.Patient diagnosed with any systemic illness or taking blood thinning medicine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of pittaja asrugdar. |
1st day,last day of first menstrual period after intervention period, last day second menstrual period after intervention period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement of quality of life.
2.Duration of bleeding less than 7 days.
3.
Amount of blood loss less than 80 ml of menstrual bleeding. |
1st day,30th day,60th day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
10/04/2025 |
| 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="6" 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
|
Abnormal uterine bleeding (AUB) is a common condition that
affects 10–30% of women of reproductive age group. Up to one-third of women
experience AUB in their lifetime.AUB can cause significant morbidity and
negatively impact a woman’s physical, social, emotional, and material quality
of life. Hence It is time to investigate and construct a clinically and
scientifically abnormal uterine bleeding management strategy that is not only
cost effective. Chronic AUB can lead to severe Anemia, Infertility &
Endometrial cancer. hence, it is need of the hour to treat this disease in
time, so that these complications can be avoided and women can lead a healthy
life. In modern medicine Hemostatic, Analgesic and Hormonal therapies are
advised for abnormal uterine bleeding. Their side effects have led to hormonal
imbalances hence it is need of time to have an integrated and comprehensive
therapeutic intervention in Ayurveda to prevent recurrence & would overcome
thelimitations of modern medicine.
In this study we choose Pradar nashak yoga
which contains Yastimadhu Haritaki Amalaki Vibhitaki Lodhr Motha,and
Sphatik Madhu as Anupaana which stop the bleeding per vagina . In
Ayurvedic classics drugs and formulations which have property of Kashaya and
Tikta rasa Sheeta veerya Katu Vipaka Shothahara Grahi Garbhashaya Balya Rakta
shodhaka Rakta-stambhana and Vatanulomana properties are described for the
treatment of Asrugdar.
A clinical study will be conducted to see the efficacy of
Pradar Nashak Yoga in pittaja asrugdar (AUB-O).At first, all participants will
be screened to check their eligibility for the study. A total of 30 clinically
diagnosed patients will be enrolled in this study after taking informed written
consent. After that, the first assessment will be done before drug
administration with a validated questionnaire and grading will be done
according to the signs and symptoms of the patients. Then the drug therapy will
be started and the total duration will be 60 days.Two follow ups will be done
each after 30 days. The last assessment will be done on the 60th day and the
grading will be given again to see the changes in the signs and symptoms of
pittja asrugdar.Signatures on informed consent and patient information sheets
will be taken on hard copy, and all other relevant data for the study will be
collected. After the collection of all the relevant data, the analysis of the
data will be done. |