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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  
self 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
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.

 
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