| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N800||Endometriosis of uterus. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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 | | 2 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (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 | | 3 | Comparator Arm (Non Ayurveda) | | - | Dienogest | 19-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. |