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CTRI Number  CTRI/2023/10/058973 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 04/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative clinical study to evaluate the effect of Shalmali Ghritha and Bola Baddha Rasa in Asrigdara (DUB) 
Scientific Title of Study   A randomized controlled clinical study to evaluate the efficacy of Shalmali Ghritha in Asrigdara (DUB)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshata Mallikarjun Mudalagi 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College , Moodbidri 
Address  Department of PG Studies Prasooti Tantra and Stree Roga Alvas Ayurveda Medical College Moodbidri Dakshina Kannada

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7829930112  
Fax    
Email  akshatamudalagi21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asokan V 
Designation  Professor and HOD 
Affiliation  Alvas Ayurveda Medical College , Moodbidri 
Address  Professor and HOD Department of PG Studies Prasooti Tantra and Stree Roga Alvas Ayurveda Medical College Moodbidri Dakshina Kannada

Dakshina Kannada
KARNATAKA
574227
India 
Phone  6361740431  
Fax    
Email  drasokan24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akshata Mallikarjun Mudalagi 
Designation  PG Scholar 
Affiliation  Alvas Ayurveda Medical College , Moodbidri 
Address  Department of PG Studies Prasooti Tantra and Stree Roga Alvas Ayurveda Medical College Moodbidri Dakshina Kannada

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7829930112  
Fax    
Email  akshatamudalagi21@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College Moodbidri  
 
Primary Sponsor  
Name  Akshata Mallikarjun Mudalagi 
Address  PG Scholar Alvas Ayurveda Medical College & Hospital, Moodbidri , Dakshin kannada 
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 
Akshata Mallikarjun Mudalagi  Alvas Ayurveda College And Hospital , Moodbidri  Department of PG Studies Prasooti Tantra And Stree Roga Alvas Ayurveda Medical College and Hospital Moodbidri , Dakshina Kannada
Dakshina Kannada
KARNATAKA 		 7829930112

akshatamudalagi21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethics Committee, Alvas Ayurveda Medical College, Moodbidri  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shalmali Ghritha, Reference: Yoga Ratnakara , Pradra chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Bola Baddha Rasa, Reference: Brihat Nighantu Ratnakara, kasa chikista., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Raja Atipravarthi – Excessive Bleeding (>/ 6 pads fully soaked per day ).
2.Deerga kala anubandhi – Prolonged Bleeding (>/ 8 days) , pervious H/O atleast 2 consecutive cycles.
3.Vedana – Pain
4.Age : 20 - 45 years
5.Patient with HB% > 8gm%
6.Both married and unmarried
 
 
ExclusionCriteria 
Details  1.Patient with history of DM, HTN, Bleeding disorders and other systemic disorders.

2.Pregnant and Lactating females.

3.Any pelvic pathologies like Endometriosis, Fibroids, Tumor, Inflammation, Benign and Malignant growth in uterus.

4.Post Abortal Bleeding.

5.Endocrinal disorders like Thyroid Dysfunction, PCOS .

6.IUCD and OCP user.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Prolonged cycle (YES/NO) 2.Duration of menstrual bleeding
3.Excessive bleeding (YES/NO) 4.Amount of menstrual bleeding
5.Pain
 		 During treatment 3rd day & 11th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Prolonged cycle (YES/NO) 2.Duration of menstrual bleeding
3.Excessive bleeding (YES/NO) 4.Amount of menstrual bleeding
5.Pain
 		 After treatment 3rd day & 11th day of next 2 consecutive menstrual cycle. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/10/2023 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 15-10-2024 and end date provided 15-10-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Many drugs are used for internal administration, external application and preventive measures have been described in Ayurveda Samhitas and modern science to overcome Asrigdara(DUB) . So a remedy which would be economical ,efficacious and benefits the larger scale of community. Therefore an attempt was made to study the clinical evaluation of Shalmali Ghritha in the management of Asrigdara and compare its efficacy with the Bola Baddha Rasa. 
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