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CTRI Number  CTRI/2025/01/079805 [Registered on: 30/01/2025] Trial Registered Prospectively
Last Modified On: 27/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Piccha basti and concentrated kutaja kashmari capsule given to treat adenomyosis and fibroid uterus in females 
Scientific Title of Study   A CLINICAL STUDY TO EVALUATE THE EFFICACY OF PICCHA BASTI AND CONCENTRATED KUTAJA KASHMARI CAPSULE IN ABNORMAL UTERINE BLEEDING W.S.R TO ADENOMYOSIS AND FIBROID UTERUS 
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 Preethi Hegde 
Designation  Post graduate resident  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118 
Address  Department of Prasooti tantra and stree roga Room no 300 Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118

Udupi
KARNATAKA
574118
India 
Phone  9449198983  
Fax    
Email  preethihegdepai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mamatha K V  
Designation  Principal  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118 
Address  Department of Prasooti tantra and stree roga Room number 300 Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118

Udupi
KARNATAKA
574118
India 
Phone  9448215605  
Fax    
Email  mamath2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mamatha K V  
Designation  Principal  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118 
Address  Department of Prasooti tantra and stree roga Room number 300 Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118

Udupi
KARNATAKA
574118
India 
Phone  9448215605  
Fax    
Email  mamath2@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118 
 
Primary Sponsor  
Name  Dr Preethi Hegde  
Address  Gurukripa Shambhavi Nagara Pervaje 2nd cross Karkala Udupi District Karnataka India 574104 
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 Mamatha K V   Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre   Department of Prasooti tantra and stree roga Room number 300 Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118
Udupi
KARNATAKA 		 9448215605

mamath2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi Institutional ethical clearance commitee- human  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-picCA/picCila-bastiH, पिच्छा/पिच्छिल-बस्तिः (Procedure Reference: Charaka samhita chikitsa sthana 14th chapter arsha chikitsa 225-228 shloka, Procedure details: Subjects will be administered with piccha basti & kutaja kashmari ghritha matrabasti alternatively for 8 days in yoga basti pattern.)
(1) Medicine Name: Kutaja kashmari ghritha , Reference: Charaka samhita chikitsa sthana 30th chapter 100-101, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 8 Days
2Intervention ArmDrugOther than Classical(1) Medicine Name: Concentrated kutaja kashmari capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lajjalu kashaya ), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Fibroids size less than 8cms
Subjects aged between 18 to 55 years 
 
ExclusionCriteria 
Details  a)Post menopausal bleeding and patients with traumatic lesion of genital tract.
b)Subjects suffering from any systemic disorders like Diabetes mellitus, Hypertension etc.
c)Subjects with other cause of Abnormal uterine bleeding such as polyp, malignancy, coagulopathy, ovulatory dysfunction
d)Anemia in which HB% is less than 6.5gm%.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in FIGO classification of uterine bleeding.
Improvement in pictorial blood loss assessment chart.
Improvement in TVUSG parameters 		 Follow up on 30th day and after 60th day.
DURATION OF STUDY: 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
To obtain an effective medical management in abnormal uterine bleeding.
Reduction in the risk of anaemia and related complications
Decrease in the incidence of Hysterectomy and other Surgical Interventions 		 60 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   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/02/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [preethihegdepai@gmail.com].

  6. For how long will this data be available start date provided 03-02-2025 and end date provided 04-02-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Abnormal uterine bleeding (AUB), particularly in cases associated with adenomyosis and fibroid uterus, significantly impacts women’s quality of life, causing physical, psychological, and social distress. Conventional treatments like hormonal therapy and hysterectomy, while effective, have limitations due to their side effects and invasive nature. This clinical study aims to evaluate the efficacy of Piccha Basti combined with concentrated Kutaja Kashmari capsules in managing AUB with special reference to adenomyosis and fibroid uterus. Thirty participants diagnosed through transvaginal ultrasonography (TVUSG) will undergo a treatment regimen comprising Piccha Basti, an Ayurvedic enema with astringent and hemostatic properties, and Kutaja Kashmari capsules for two months. The intervention seeks to reduce symptoms like excessive menstrual bleeding and pain while improving TVUSG findings. Outcome measures include subjective parameters like bleeding duration and pain intensity and objective parameters such as endometrial thickness and DEERS criteria.This study explores a holistic Ayurvedic approach to mitigate the adverse effects of conventional treatments and improve patient outcomes

 
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