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CTRI Number  CTRI/2021/02/031090 [Registered on: 08/02/2021] Trial Registered Prospectively
Last Modified On: 05/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of certain oral drugs in heavy menstrual bleeding. 
Scientific Title of Study   A comparative clinical study of Nāgakesara CÅ«rnÌ£a and KutakÄ« CÅ«rnÌ£a in the management of AsrÌ£gdara with special reference to Dysfunctional Uterine Bleeding. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Hemantha Kumar 
Designation  Professor & HOD 
Affiliation  National Institute of Ayurveda 
Address  P.G.Department of Shalya Tantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Hemantha Kumar 
Designation  Professor & HOD 
Affiliation  National Institute of Ayurveda 
Address  P.G.Department of Shalya Tantra, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur


RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonu  
Designation  Lecturer 
Affiliation  National Institute of Ayurveda 
Address  P.G.Department of Prasuti Tantra and Stri Roga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  7597056107  
Fax    
Email  89sonu123@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan (302002) 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  P.G. Department of Prasuti Tantra and Stri Roga, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur 
Type of Sponsor  Research institution and hospital 
 
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 Sonu  National Institute of Ayurveda, Jaipur  OPD no. 26 & 27, P.G.Department of Prasuti Tantra and Stri Roga, Jaipur
Jaipur
RAJASTHAN 		 7597056107

89sonu123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N938||Other specified abnormal uterine and vaginal bleeding. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  KutakÄ« CÅ«rnÌ£a  Oral intake of 3 gram of KutakÄ« CÅ«rnÌ£a with Sahapana of DrākÅ›a and Sitā and Anupana of TanÌ£dÌ£ulodaka(200 ml) before meal twice a day for 60 days 
Intervention  Nāgakesara CÅ«rnÌ£a   Oral intake of 6 gram of Nāgakesara CÅ«rnÌ£a with Sahapana of NavanÄ«ta and Åšarkarā and Anupana of TanÌ£dÌ£ulodaka (200 ml) before meal twice a day for 60 days 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1) Patients ready to participate in the clinical trial.
2) Patients diagnosed as dysfunctional uterine bleeding.
3) Excessive menstrual bleeding (amount >80 ml) or Prolonged menstrual bleeding (>7 days) with or without heavy flow or Frequent menstrual cycle (interval< 21 days)
4) Patients presenting with inter-menstrual bleeding with or without heavy flow for 2 consecutive cycles.
 
 
ExclusionCriteria 
Details  1) Patients with chronic systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, Tuberculosis endometritis, severe anaemia, chronic renal disease, Insulin dependent diabetes mellitus etc.).
2) Patients using Intrauterine contraceptive device or oral contraceptive pills (Iatrogenic).
3) Patients with uterine and pelvic pathology (Fibroid size >2 cm, endometriosis, adenomyosis, polyp, high grade cervical erosion, endometrial thickness >20 mm etc.).
4) Congenital malformations of uterus(Septate uterus, double uterus).
5) Benign and malignant growth.
6) Thyroid dysfunction (endocrinal disorders).
7) Patients having bleeding due to abortion, ectopic pregnancy, during puerperium.
8) Patients taking Anti-coagulation therapy and having haematological disorders (Leukemia, Thrombocytopenic Purpura).
9) Postmenopausal bleeding.
10) Sexually transmitted infections/Genital tract infections.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy (reduction in complaints of DUB)  2 months  
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse event reported voluntarily, observed or enquired  3 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)   01/03/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dysfunctional uterine bleeding occurs most commonly at the extremes of reproductive age (20% of cases occur in adolescence and 40% in patients over age 40).Various treatments are available in modern medicine such as hormones therapy, anti-fibrinolytic agents, anti-prostaglandins etc. but have not proved their definite efficacy in spite of high cost and side effects. Although the medical therapy is generally used first, excessive menstrual bleeding accounts for two third of all hysterectomies.So, there is great scope of research to find out safe, potent, cost effective remedy from Ä€yurvedaby addressing the root of the problem thereby improving the quality of life of women. This study will be carried out to evaluate the efficacy of Nāgakesara CÅ«rnÌ£a and KutakÄ« CÅ«rnÌ£a in AsrÌ£gdara and to know about the possible aetiology of Asrigdara. Patients will be selected from O.P.D. and I.P.D. of PrasutiTantra and StriRoga Department of N.I.A., Jaipur as per criteria. Written voluntary informed consent will be taken from each patient before starting the trial. The clinical study will be conducted on minimum hundred clinically diagnosed patients of AsrÌ£gdara and randomly divided into two groups. An observational study about the Nidāna of AsrÌ£gdara will also be carried out by making a questionnaire among minimum two hundred patients. All the patients registered for the present trial will be assessed on the basis of subjective parameters, objective parameters and laboratory investigations and Pictorial blood loss assessment chart (PBLAC) and SF-36 questionnaire for quality of life.

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