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CTRI Number  CTRI/2025/11/097192 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 09/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study on the effect of Amarsundari Vati and Chandanbala Lakshadi Taila Matra Basti in management of heavy menstrual bleeding Asrigdara 
Scientific Title of Study   Efficacy of Amarsundari vati and Chandanbala Lakshadi Taila Matra Basti in the management of Asrigdara A single arm 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  Dr Laxmi Devi 
Designation  PG Scholar 
Affiliation  All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi 
Address  Room No. 405,Seminar room,Fourth floor,Academic Block All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi

South
DELHI
110076
India 
Phone  06387478949  
Fax    
Email  situsuman2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Kadam 
Designation  Head of Department 
Affiliation  All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi 
Address  Room No. 405,Seminar room,Fourth floor,Academic Block All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi

South
DELHI
110076
India 
Phone  9890305370  
Fax    
Email  sujatadkadam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujata Kadam 
Designation  Head of Department 
Affiliation  All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi 
Address  Room No. 405,Seminar room,Fourth floor,Academic Block All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi

South
DELHI
110076
India 
Phone  9890305370  
Fax    
Email  sujatadkadam@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  405 Seminar Hall Department Of Stri Roga And Prasuti Tantra ALL India Institute Of Ayurveda Sarita Vihar New Delhi 110076 India 
Type of Sponsor  Government medical college 
 
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 Laxmi Devi  OPD NO 203 All India Institute Of Ayurveda  Room No. 405,Seminar room,Fourth floor,Academic Block All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi Room No. 405,Seminar room,Fourth floor,Academic Block All India Institute Of Ayurveda Gautampuri Sarita vihar New Delhi 110076 South Delhi
South
DELHI 		 06387478949

situsuman2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALETHICSCOMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N926||Irregular menstruation, unspecified. Ayurveda Condition: ARTAVAVRUDDHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Amarasundarivati, Reference: Bhaishajyasarasangraha Bhasma Prakarana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: N/A
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women of reproductive age group 18-45years
Patients with symptoms of heavy and prolonged menstrual bleeding or intermenstrual bleeding
Patients willing for trial will be selected
Patient with simple ovarian cyst
 
 
ExclusionCriteria 
Details  Patients with any diagnosed uterine organic pathology like Uterine Fibroid, ChronicTubo-ovarian mass.
Patients with systemic diseases like hypertension, diabetes mellitus, congestive cardiac failure etc.
Patients with coagulopathy, liver and thyroid dysfunction etc.
Patients with malignancy or undiagnosed neoplasm.
Patients with history of recent abortion.
Patients with active genital tuberculosis
Pregnant and Lactating women.
IUCD in utero, pelvic endometriosis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of combination of Amarsundari vati with Chandanbala taila Matra basti for treating heavy and/ or prolonged menstrual bleeding or intermenstrual bleeding in terms of amount of menstrual blood loss in cases of Asrigdar (Menorrhagia)  To evaluate the clinical efficacy of combination of Amarsundari vati with Chandanbala taila Matra basti for treating heavy and/ or prolonged menstrual bleeding or intermenstrual bleeding in terms of amount of menstrual blood loss in cases of Asrigdara (Menorrhagia) 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the clinical efficacy of the drug on the change in endometrial thickness & improvement in haemoglobin level  To evaluate the clinical efficacy of the drug on the change in endometrial thickness & improvement in haemoglobin level 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 1/ Phase 2 
Date of First Enrollment (India)   05/01/2026 
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="0"
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  

Title:
Efficacy of Amarsundari Vati and Chandanbala Lakshadi Taila Matra Basti in the Management of Asrigdara – A Single Arm Clinical Study

Scholar:
Dr. Laxmi Devi, M.S. (Ayu.) Scholar, Department of Stri Roga and Prasuti Tantra, AIIA, New Delhi

Guide: Prof. Dr. Sujata Kadam
Co-Guides: Dr. Swati Gaikwad, Dr. Tejaswini D. Buchade

Overview:

This clinical study evaluates the combined efficacy of Amarsundari Vati (250 mg twice daily) and Chandanbala Lakshadi Taila Matra Basti (75 ml rectally for 7 days each month) in managing Asrigdara (Menorrhagia/Abnormal Uterine Bleeding).

Aim & Objectives:

  • Primary: To assess the efficacy of the combined therapy in reducing heavy, prolonged, or intermenstrual bleeding.

  • Secondary: To evaluate changes in endometrial thickness and hemoglobin levels.

Methodology:

  • Study Type: Single arm, open-label clinical study

  • Sample Size: 32 female patients aged 18–45 years

  • Duration: 3 months treatment + 1 month follow-up

  • Setting: OPD/IPD, Dept. of Stri Roga and Prasuti Tantra, AIIA

Assessment Parameters:

  • Subjective: Duration and amount of bleeding, intermenstrual period, abdominal and back pain (graded scales).

  • Objective: CBC, USG pelvis, hormonal and coagulation profiles, Hb levels.

Expected Outcome:

The combination therapy is expected to significantly reduce menstrual blood loss, normalize cycles, and improve uterine health and anemia with minimal side effects.

 
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