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CTRI Number  CTRI/2024/10/075920 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 18/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic Management of Heavy Menstrual Bleeding and pain during menstruation 
Scientific Title of Study   The effect of Mustadigana Kwatha orally and Palashakshara Yamaka Uttarbasti versus Dienogest in the management of Adenomyosis-An open label randomised controlled clinical trial 
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 Vimmi 
Designation  PG Scholar 
Affiliation  Shri Dhanwantry Ayurvedic College and Hospital 
Address  Room No. - A-205,Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  8360695852  
Fax    
Email  vimmiaadia98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Archana S 
Designation  Associate Professor 
Affiliation  Shri Dhanwantry Ayurvedic College and hospital sector 46 b chandigarh 
Address  Room No. - A-205,Department of Prasuti Tantra evam Stree Roga Shri Dhanwantry Ayurvedic College and hospital sector 46 b chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9447767909  
Fax    
Email  archanas875@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Archana S 
Designation  Associate Professor 
Affiliation  Shri Dhanwantry Ayurvedic College and hospital sector 46 b chandigarh 
Address  Room No. - A-205,Department of Prasuti Tantra evam Stree Roga Shri Dhanwantry Ayurvedic College and hospital sector 46 b chandigarh

Chandigarh
CHANDIGARH
160047
India 
Phone  9447767909  
Fax    
Email  archanas875@gmail.com  
 
Source of Monetary or Material Support  
Shri Dhanwantry Ayurvedi College and Hospital Sector 46 B Chandigarh Pincode 160047 India  
 
Primary Sponsor  
Name  Dr Vimmi  
Address  Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh Pincode 160047 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 vimmi  Shri Dhanwantry Ayurvedic College and Hospital , Sector 46 B Chandigarh Pincode 160047 India  Room No. 105 Prasuti Tantra evam Stree Roga OPD
Chandigarh
CHANDIGARH 
8360695852

vimmiaadia98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Dhanwantry Ayurvedic College and Hospital Sector 46 B Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N800||Endometriosis of uterus. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mustadigana Kwatha, Reference: Sushrut Samhita Sutrasthana Adhyaya 38 verse 54, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -jaggery), Additional Information: -Dose of jaggery - 3gm with kwatha
2Intervention ArmProcedure-uttara-bastiH, उत्तर-बस्तिः (Procedure Reference: Charak Samhita Siddhisthana Adhyaya 9 Verse 67-68, Procedure details: Palasha kshara yamaka to be instilled into intrauterine cavity through vagina in lithotomy position under aseptic conditions for 3 alternative days after cessation of menstruation )
(1) Medicine Name: Palasha Kshara Yamaka , Reference: Charak Samhita Chikitsa Sthana Adhyaya 5 Verse 173, Route: Vaginal, Dosage Form: Not Applicable, Dose: 3(ml), Frequency: od, Duration: 3 Months
3Comparator Arm (Non Ayurveda)-Dienogest19-nortestosterone derivative , dose - 2mg BD To be given for 3 months
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  symptomatic subjects having pure Adenomyosis or dominant adenomyosis concurrent with uterine fibroids or endometriosis through USG,
Subjects presenting with any one complaint like menorrhagia (Heavy menstrual bleeding), Dysmenorrhea and chronic pelvic pain
Married women with informed written consent,
Subjects who are fit for Intrauterine Uttarbasti 
 
ExclusionCriteria 
Details  Uterine fibroids more than 5cm size.
Pregnancy and lactation
Uncontrolled hyperthyroidism and hypothyroidism, uncontrolled Hypertension,
Diabetes Mellitus 2
Subjects with any congenital disorders
Subjects with confirmed coagulopathy (based on signs and symptoms)
Hb less than 8 gm/dl
Active genital infections
Adenomyosis along with endometriotic cyst more than 5cm
Endometrial thickness more than 11mm
Undiagnosed abnormal vaginal bleeding with in the last 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
decrease in PBAC score,
changes in VAS pain score per cycle 
from 0th to 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of uterine volume/ size of uterus and myometrial cyst (if any) evidenced by USG  From 0th to 90th day 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/11/2024 
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="3"
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  

Adenomyosis is the presence of ectopic endometrial glands within underlying myometrium. It is frequently diagnosed in young and infertile women. This disease is associated with pain or Abnormal uterine bleeding or both.  This trial is to evaluate and compare the combined effect of Mustadigana kwatha orally along with Palashkshara yamaka uttarbasti  versus Dienogest in managing adenomyosis and improving the quality of life .The trial will be performed in two groups consisting of 25 patients in each group. One group will be given Ayurvedic Management and the second group will receive Dienogest (2mg BD) for 3 consecutive months. The inclusion criteria includes -symptomatic patients have pure or dominant adenomyosis concurrent with uterine fibroids or endometriosis through USG , married women between age group of 30-45 years, those who are fit for Intrauterine Uttarbasti. Whereas exclusion criteria involves the patient having fribroids and endometriotic cyst of more than 5cm in size and endometrial thickness more than 11mm , Hb less than 8gm/dl , any congenital abnormalities, pregnant and lactating women,  uncontrolled hypertension or hyperthyroidism or hypothyroidism , uncontrolled Diabetes Mellitus. The primary expected outcome is decrease in PBAC score and VAS pain score , whereas secondary expected outcome is reduction of uterine volume / size of uterus and myometrial cysts (if any) evidenced by USG.

 
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