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CTRI Number  CTRI/2025/09/095155 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 19/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Evaluation The Effect Of Amalaki Beeja Churna In Asrigdara 
Scientific Title of Study   Clinical Evaluation Of Amalaki Beeja Churna In Asrigdara W.S.R To Dysfunctional Uterine Bleeding 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dr G M Kavya 
Designation  Associate Professor 
Affiliation  Rishikul Campus Haridwar 
Address  P.G Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand
P.G Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249401
India 
Phone  9902345121  
Fax    
Email  dr.kavyajain@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr G M Kavya 
Designation  Associate Professor 
Affiliation  Rishikul Campus Haridwar 
Address  P.G Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand
P.G Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249401
India 
Phone  9902345121  
Fax    
Email  dr.kavyajain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aradhana Gupta 
Designation  Post Graduation Scholar 
Affiliation  Rishikul Campus Haridwar 
Address  P.G Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand
P.G Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand
Hardwar
UTTARANCHAL
249401
India 
Phone  9721160703  
Fax    
Email  garadhana14@gmail.com  
 
Source of Monetary or Material Support  
PG Department Of Prasuti Tantra Evum Stree Roga OPD 9 Rishikul Campus Haridwar Uttarakhand Ayurved University 
 
Primary Sponsor  
Name  Rishikul Campus Haridwar 
Address  Rishikul Campus Haridwar Uttarakhand Ayurved University OPD no 9 Devpura Haridwar 249401  
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 
Aradhana Gupta  Rishikul Campus Haridwar  OPD No. 9 PG Department Of Prasuti Tantra Evum Stree Roga, Rishikul Campus Haridwar, Uttarakhand Ayuveda University Haridwar, Uttaranchal
Hardwar
UTTARANCHAL 		 9721160703

garadahana14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituional Ethical Committee  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 ArmDrugClassical(1) Medicine Name: Amalaki Beeja Churna , Reference: Shodhal Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu & Ghrita In Visham Matra), Additional Information: Sahapana is Madhu & Ghrita In Visham Matra
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Married and unmarried females
Females having Chief complaint of excessive bleeding Per vaginum during menses either in amount or duration or both or during short inter menstrual period for 3 consecutive cycles
Patients having normal BMI
Hb more than 8 gm per dl
 
 
ExclusionCriteria 
Details  Patients having systemic diseases like Hypertension, Diabetes Mellitus, Tuberculosis, Thyroid dysfunction, Blood Coagulopathies
Women of Penmenopausal & Postmenopausal age
Pregnant women, Post partum females
Patient having H/O recent Abortion
Patient suffering from DUB complicated by non-responding Anemia
Patient having organic pathology like Cervical or Uterine Polyp, Uterine Fibroids, PID
Patients using OCP (Oral Contraceptive Pills), IUCD (Intra Uterine Contraceptive Device) or taking hormonal treatment 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reduction In Amount Of Heavy Bleeding   2 Month 
 
Secondary Outcome  
Outcome  TimePoints 
Significant Improvement In Associated Symptoms Like Lower Backache & Generalised Weakness  1 Month 
 
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)   03/10/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Asrigdara, described in Ayurvedic classics, correlates with Dysfunctional Uterine Bleeding (DUB), which is excessive or irregular uterine bleeding without identifiable organic pathology. It is a common gynecological disorder causing significant morbidity in women of reproductive age. Current management options often involve hormonal or surgical interventions with potential side effects, hence there is a need for safe, cost-effective alternatives.

Amalaki (Emblica officinalis) is a well-known Ayurvedic drug with Tridoshaghna, Rasayana, and haemostatic properties. Its seed powder (Amalaki Beeja Churna), rich in Vitamin C, tannins, and gallic acid, is traditionally indicated in bleeding disorders. This clinical trial aims to evaluate its efficacy in Asrigdara/DUB.

An open-label clinical study will be conducted on 30 female patients (16-45 years) diagnosed with Asrigdara/DUB attending OPD/IPD of Prasuti Tantra Evam Stree Roga. The intervention will be Amalaki Beeja Churna 6 g twice daily with honey and ghee for 3 consecutive menstrual cycles, with follow-up for 2 cycles.

Assessment will be based on subjective parameters (duration of bleeding, flow, pain, clots, associated symptoms) and objective parameters (Hb. blood loss, endometrial thickness).

This study aims to establish a safe, affordable herbal alternative for the management of Asrigdara/DUB.

 
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