FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081019 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of abnormal uterine bleeding (Asrikdara) with coded Ayurvedic formulation- AYUSH-LND 
Scientific Title of Study   Effectiveness and safety of AYUSH-LND (coded Ayurvedic formulation) in the Management of abnormal uterine bleeding (Asrikdara): an Open label single arm prospective clinical study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vd Priya Ashokrao Thakare 
Designation  Research Officer (Ayu.) 
Affiliation  Regional Ayurveda Research Institute, Nagpur 
Address  Regional Ayurveda Research Institute, Nagpur Near Gharkul Parisar, N.I.T. complex, Nandanvan, Nagpur, Maharshtra -

Nagpur
MAHARASHTRA
440024
India 
Phone  9175418356  
Fax    
Email  ard123md@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Shinde 
Designation  Research Officer (Ayu.) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar Lal Nehru Bhartiya Chikitsa evam Homoepathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  9623011214  
Fax    
Email  drshindeprashant007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashant Shinde 
Designation  Research Officer (Ayu.) 
Affiliation  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar Lal Nehru Bhartiya Chikitsa evam Homoepathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi

New Delhi
DELHI
110058
India 
Phone  9623011214  
Fax    
Email  drshindeprashant007@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa evam Homoepathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-58. (Ministry of AYUSH, Government of India) 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  Jawahar Lal Nehru Bhartiya Chikitsa evam Homoepathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smritika Taware  Dr. D.Y.Patil College of Ayurved and Research Centre, Pimpri, Pune  Streeroga evam Prasutitanta Department, Dr. D. Y. Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA 		 9850967067
020-27805899
bhonsalesmritika@gmail.com 
Dr Shilpakumari B Donga  Institute of Teaching and Research in Ayurved, (ITRA),Jamnagar  Streeroga evam Prasutitanta Department, ITRA, Opp. City B division Police Station, Gurudwara Road, Jamnagar, Gujrat 361008
Jamnagar
GUJARAT 		 9825646796

drshilpadonga@yahoo.com 
Dr Bharathi Kumaramangalam  National Institute of Ayurveda (DU), Jaipur   Streeroga evam Prasutitanta Department, NIA, Madhav Vilas Palace, Amer Rd, Jaipur, Rajasthan 302002
Jaipur
RAJASTHAN 		 9492047131
91-141-263-5709
baruhunt@gmail.com 
Dr Mamatha KV  Shri Dharmasthala Manjunatheshwara College of Ayurveda, Udupi, Karnataka  Streeroga evam Prasutitanta Department, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Laxminarayana Nagara, Post Kuthpady, Udupi Taluka & District – 574118, Karnataka, India
Udupi
KARNATAKA 		 9448215605
0820-2533790
mamath2@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethical Clearance Committee Human  Approved 
Institutional Ethics Committee (IEC)  Approved 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
Institutional Ethics Committee, ITRA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N939||Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: AYUSH-LND, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: Coded formulation
2Intervention ArmDrugClassical(1) Medicine Name: Dhatri Lauha, Reference: AFI Part 1 – Vol. 5, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  i. Women Age between 18-40 years with heavy menstrual bleeding with no definable organic cause and having complaints of excessive bleeding during menstruation (classified according to PALM – COEIN Classification (bleeding due to coagulopathy, Ovulatory dysfunction, endometrial, iatrogenic and not yet classified will be included.) (Pictorial blood loss assessment chart (PBLAC) score more than 100 points) or prolonged bleeding i.e. bleeding more than 7days for 3 consecutive cycles; ii. Willing and able to comply with schedules visits, treatment, and assessments.  
 
ExclusionCriteria 
Details  i. Hb less than 8 gm.
ii. Endometrial Hyperplasia diagnosed radiologically with endometrial thickness more than 20 mm in secretory phase
iii. Associated with reproductive system abnormalities (Excluded clinically and radiologically) or diagnosed Pelvic Inflammatory Disease, Cervicitis, Hydrosalpinx, Endometriosis, Fibroid Uterus, Carcinoma of Reproductive Organ, adenomyosis
iv. Other causes of excessive menstrual bleeding e.g. Thyroid disease, Incomplete Abortion, abortion in last three months, presence of an IUCD.
v. Participants on prolonged (more than 6 weeks) drugs which can cause Abnormal Uterine Bleeding e.g. Anticoagulants, Acetylsalicylic acid, Antidepressants (Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants), Hormone Replacement Therapy, Tamoxifen, Phenothiazines, Corticosteroids, Thyroxine, Oral Contraceptives products or any other drugs that may have an influence on the outcome of the study.
vi. Lactating woman and women expecting to conceive within next 4 months.
vii. Participants who have a past history of Atrial Fibrillation,Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
viii. Participant with raised liver enzymes twice the upper limit of normal & creatinine more than 1.4, poorly controlled Hypertension (more than 160/100 mm of Hg), poorly controlled Diabetes Mellitus{B.S. (F) more than 130 mg and or Blood Sugar (2 hr. PP) more than 250 mg and HbA1c more than 6.5}.
ix. Ingestion of any investigational drug within 4 weeks prior to recruitment in the study.
x. Participants who are currently participating in any other clinical trial or participated in past four weeks.
xi. Any other condition which the Principal Investigator thinks may jeopardize the study
xii. Women who are on hormonal therapy for AUB may be included after washout period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart
ii.Change in the laboratory safety parameters (LFT, KFT) 		 Changes in the score denoting amount of menstrual blood loss in women by means of PBLAC (Pictorial Blood Loss Assessment Chart [Time frame: Baseline, every cycle up to 4 cycles].
ii. Change in the laboratory safety parameters (LFT, KFT) baseline [Time frame: Baseline, end of the 4th cycles]. 
 
Secondary Outcome  
Outcome  TimePoints 
No of participants with normal cycles at 120 days (restoration of normal menstrual cycle Duration 5-7 days and interval 21-35 days)  Baseline, every cycle up to 4 cycles 
Change in score of Menorrhagia Impact Questionnaire.   Baseline, every cycle up to 4 cycles 
iii. Assessment of treatment adherence through participant self-reported compliance log and used medication containers/strips   Baseline, every cycle up to 4 cycles 
iv. Assessment of the tolerability of AYUSH-LND (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study period  Baseline, every cycle up to 4 cycles 
Change in the laboratory parameters from baseline (Complete Blood Count, Test Sr. FSH, Sr. LH, Sr. estradiol)  baseline, and 120th day 
 
Target Sample Size   Total Sample Size="560"
Sample Size from India="560" 
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 3 
Date of First Enrollment (India)   26/02/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 defined as any alteration in the pattern or volume of menstrual blood flow. As per American College of Obstetrics & Gynaecology Abnormal Uterine Bleeding (AUB) is occurred in conditions such as bleeding between periods, bleeding after sex, spotting anytime in the menstrual cycle or for more days than normal, bleeding after menopause. Menstrual cycles that are longer than 35 days or shorter than 21 days are abnormal and it can occur at any age. It can have a substantial financial and quality-of-life burden. It affects women’s health both medically and socially. In India, the reported prevalence of AUB is around 17.9%. A randomized clinical study was already conducted by CCRAS on Abnormal uterine bleeding using Ayurvedic formulation Tab. AYUSH LND (Analysis was done but results are not published) found statistically more significant than conventional therapy in the heavy menstrual bleeding. Previous study was done in controlled environment, so this study is proposed to conduct on tolerability and treatment adherence in large population. 

 
Close