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CTRI Number  CTRI/2026/03/105485 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 05/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Ashoka Twak Ksheerpak Taken Orally Followed by Ashoka Ghrita Uttarbasti in Women with Abnormal Uterine Bleeding. 
Scientific Title of Study   A single arm clinical study to evaluate the combined effect of ashoka twaka ksheerpaka orally followed by ashoka ghruta uttarbasti in asrugdara [abnormal uterine bleeding (AUB)]. 
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 Snehal Zole 
Designation  PG scholar 
Affiliation  Seth Govindaji Raoji Ayurved Mahavidyaly Solapur 
Address  OPD no 4 Prasutitantra evum streerog department , Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukrawar peth, near juni faujdar chowdi , Solapur Maharashtra 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  7028315108  
Fax    
Email  snehal.zole@pg.sgrayurved.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Jawale 
Designation  HOD, Prasuti Tantra evum Streerog department 
Affiliation  Seth Govindaji Raoji Ayurved Mahavidyaly Solapur 
Address  OPD no 4 Prasutitantra evum streerog department , Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukrawar peth, near juni faujdar chowdi , Solapur Maharashtra 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  9028244410  
Fax    
Email  veena.jawale@sgrayurved.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Zole 
Designation  PG scholar 
Affiliation  Seth Govindaji Raoji Ayurved Mahavidyaly Solapur 
Address  OPD no 4 Prasutitantra evum streerog department , Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukrawar peth, near juni faujdar chowdi , Solapur Maharashtra 413002 India

Solapur
MAHARASHTRA
413002
India 
Phone  7028315108  
Fax    
Email  snehal.zole@pg.sgrayurved.edu.in  
 
Source of Monetary or Material Support  
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukruvar peth, near juni faujdar chowki , Solapur Maharashtra 413002 India Solapur MAHARASHTRA 413002 India 
 
Primary Sponsor  
Name  Dr. Snehal Zole 
Address  Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukruvar peth, near juni faujdar chowki , Solapur Maharashtra 413002 India Solapur MAHARASHTRA 413002 India 
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 
Dr Snehal Zole  Seth Sakharam Nemchand Jain Ayurved Rugnalaya,solapur  OPD no 4 Prasutitantra evum streerog department , Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119 Shukrawar peth, near juni faujdar chowdi , Solapur Maharashtra 413002 India Solapur MAHARASHTRA 413002 India
Solapur
MAHARASHTRA 		 07028315108

snehal.zole@pg.sgrayurved.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Seth Govindji Raoji ayurved Mahavidyalya ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R938||Abnormal findings on diagnostic imaging of other specified body structures. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak samhita, Procedure details: administration of drug through vaginal route once a day for 5 day for three consecutive menstrual cycle.)
(1) Medicine Name: ashok ghrita, Reference: bhaishajya ratnavali, Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 5 Days
2Intervention ArmDrugClassical(1) Medicine Name: ashoka twak ksheerpak, Reference: bhavprakash, Route: Oral, Dosage Form: Ksheerpaka, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1)Subjects with classical symptoms of Asrugdara(AUB).
2)Subjects are in the age group of 20-50 yrs.
3)Subjects who are married.
 
 
ExclusionCriteria 
Details  1)Subject having STD.
2)Subject having PID.
3)Subjects having Coagulopathic Disorder.
4)Subjects having CA cervix.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the combined effect of ashoka twaka ksheerpaka orally followed by ashoka ghruta uttarbasti in asrugdara [abnormal uterine bleeding (AUB)].  To evaluate the combined effect of ashoka twaka ksheerpaka orally followed by ashoka ghruta uttarbasti in asrugdara [abnormal uterine bleeding (AUB)]. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate reduction in the endometrial thickness
2)To evaluate improvement in frequency, volume and duration of menstrual cycle.
 		 90 days 
 
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)   16/03/2026 
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="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 - NO
Brief Summary         Abnormal uterine bleeding (AUB) is defined as any uterine bleeding that differs from the normal volume, duration, regularity, or frequency of the menstrual cycle. Nearly 17.9% of gynecological outpatient visits are due to AUB. It is categorized as blood loss greater than 80 ml, duration of bleeding more than 8 days, cycle length less than 24 days, or variation in cycle length equal to or greater than 10 days. 
      In Ayurveda, excessive excretion of Raja is termed Pradara and due to excessive discharge of Asruka it is known as Asrugdara. Because of the limitations of current medical and surgical treatments in modern medicine, there is a need to identify an effective, non surgical, and safe Ayurvedic therapy. Ayurvedic texts describe various treatment modalities for Asrugdara, among which Ashoka Twaka Ksheerpaka is selected for its Raktastambhaka, Garbhashaya Sankochaka, Vedanasthapaka, and Balya properties. Basti therapy is considered supreme in the management of Asrugdara. 
     The study was conducted by administering 50 ml of Ashoka Twaka Ksheerpaka orally twice daily from the fourth to the eighth day of menstruation, followed by 5 ml of Uttarbasti with Ashoka Ghrita once daily from the eighth to the twelfth day of menstruation for three consecutive menstrual cycles
 
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