| CTRI Number |
CTRI/2025/02/080422 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [madhutailika vasti] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of guduchyadi kashaya and musalikhadiradi kashaya along with madhutailika vasti in Adenomyosis |
|
Scientific Title of Study
|
Effect of selected Ayurvedic interventions in Adenomyosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meshram Akanksha Yashwant |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura, Ernakulum, Kerala 682301 |
| Address |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulum, Kerala 682301
Ernakulam
KERALA
682301
India |
| Phone |
8657443783 |
| Fax |
|
| Email |
akankshameshram25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajitha R Warriar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura, Ernakulum, Kerala 682301 |
| Address |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulum, Kerala 682301
Ernakulam
KERALA
682301
India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajitha R Warriar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Tripunithura, Ernakulum, Kerala 682301 |
| Address |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulum, Kerala 682301
KERALA
682301
India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura, Ernakulum, Kerala, India 682301 |
|
|
Primary Sponsor
|
| Name |
Meshram Akanksha Yashwant |
| Address |
PG Scholar
Department of Prasuti tantra and Streeroga , Government Ayurveda College Tripunithura, Ernakulum, Kerala 682301 |
| 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 |
| DrMeshram Akanksha Yashwant |
Government Ayurveda College and hospital Tripunithura |
Department of prasutitantra and streeroga,ground floor,hospital building,682301
Ernakulam
KERALA |
8657443783
akankshameshram25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research (Institutional Review Board), Govt. Ayurveda College, Tripunithura, Kochi, Kerala-682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: guduchyadi kashaya, Reference: ashtang hridayam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: musalikhadiradi kashaya, Reference: sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Intervention Arm | Procedure | - | mAdhutailikabastiH, माधुतैलिकबस्तिः | (Procedure Reference: Susruta samhita, Procedure details: Madhutailika vasti will be administered for 3 days in 3 consecutive menstrual cycles )
(1) Medicine Name: Dhanwantaram taila, Reference: Adhtang hridayam shareersthana, Route: Rectal, Dosage Form: Taila, Dose: 204(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Shatpushpa+yadhtimadhu kalka, Reference: Ashtang hridayam kalpasthana, Route: Rectal, Dosage Form: Kalka/ Paste, Dose: 24(g), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 20-50 diagnosed with adenomyosis in USG and willing to give written informed consent
2.patients with dysmenorrhea and/or menorrhagia
3.patient with regular menstrual cycle
4.patients who are fit for madhutailika vasti |
|
| ExclusionCriteria |
| Details |
severe anemia hb less than 7gm percentage pregnant or lactating women patients having any type of malignancies or congenital anomalies of reproductive tract patients with hiv vdrl hbsag positive |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of dysmenorrhea-will be measured by Visual Analogue scale
2.Assessment of menorrhagia- will be measured by Pictorial Blood Loss Assessment Chart. |
at the end of each menstrual cycle for 3 consecutive cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of adenomyotic changes - will be done by USG (abdomen & pelvis- Adenomyotic foci either
diffuse or focal, uterine volume in cc, endometrial thickness in mm). |
at the end of third menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
20/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/02/2025 |
| 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 Yet Recruiting |
| 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 a benign uterine disorder characterized by the presence of endometrial
glands and stroma in the myometrium. menorrhagia and congestive dysmenorrhea are the
typical symptoms of adenomyosis. The enlarged and tender uterus causes dyspareunia or
frequent urination. Dyspareunia and chronic pelvic pain are the less common symptoms of
adenomyosis that are discussed. Adenomyosis causes a higher incidence of infertility and
miscarriage in women.
NSAIDs (nonsteroidal anti-inflammatory drugs), GnRH agonists, DANAZOL, and LNG-IUS
(levonorgestrel-releasing intrauterine system) loaded intrauterine devices have shown success
in reducing the symptoms of menorrhagia and dysmenorrhea associated with adenomyosis.
However, these therapies may not be entirely effective for some patients. In situations where
medicinal care is insufficient, conservative surgical procedures such as adenomyomectomy,
uterine artery embolization, and uterine mass reduction techniques can be used. If all other
medical treatment fails,total hysterectomy may be the only option left to improve the patient’s
condition.
Adenomyosis can be understood as a condition in which there is a vitiated vata and pitta
doshas causing Artavaha Dushti in the form of menorrhagia and dysmenorrhea. The
involvement of vitiated kapha dosha could be considered in cases of adhesion formation and
adenomyoma. So, the ayurvedic interventions includes Guduchyadi Kashaya, mentioned in
Ashtanga Hridaya Sutrasthana, Shodhanadi Gana Sangraha Adhyaya indicated for PittaKapha related disorders and Musalikhadiradi Kashaya, as mentioned in the Kashaya
Prakaran of Sahasrayogam, indicated for Pradara Rogas along with madhu as anupana
Another essential treatment is Madhutailika Vasti, a unique type of Vasti containing Madhu
and Taila as main ingredients. This Vasti contains drugs with mridu Veerya, exhibiting broadspectrum efficacy (phalam cha vipulam drishtam) and minimal complications (vyapadam cha
api asambhavaha). Madhutailika Vasti combines the lekhana properties of niruha vasti and
brimhana properties of sneha vasti, making it a comprehensive treatment option selected for
the study.
The study design is an interventional pre and post-study, 26 subjects aged 20-50 years,
diagnosed with adenomyosis by USG findings, having dysmenorrhea & menorrhagia
following the inclusion and exclusion criteria will be taken for the study. Data collection will
be done by clinical observation through case proforma and relevant investigations will also
be done. Oral administration of 48 ml Guduchyadi Kashaya and Musalikhadiradi Kashaya in
combination with 6gm madhu, twice daily 1hour before food for 3 consecutive menstrual
cycle and Madhutailika vasti for 3 days in the secretory phase of a menstrual cycle for 3
consecutive cycles. The patient will be assessed at the end of each menstrual cycle.
3
Menorrhagia is assessed by the Pictorial Blood Loss Assessment Chart (PBLAC score) and
dysmenorrhea is assessed by the Visual Analogue Scale (VAS). The Adenomyotic changes
are assessed by USG (abdomen & pelvis). The data collected will be statistically analyzed
through appropriate tests and a conclusion will be drawn. |