Condition category
Urological and Genital Diseases
Date applied
24/01/2019
Date assigned
11/02/2019
Last edited
11/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and aim of study:
Uterine fibroids called leiomyomas or myomas are the most common growth of the female womb. This growth (tumour) occurs in 20%–40% of childbearing age women, causing heavy menstrual bleeding, painful menstruation, and back pain. These problems can have a remarkable influence on women’s health. To date, most treatments for fibroid has been surgical, either removing the growth or the whole womb (hysterectomy). Surgical interventions require general anesthesia, lengthy hospital stays, and long recovery periods, presenting hardships for women working at home and in the work force. Furthermore, hysterectomy does not allow women to preserve their fertility. Therefore women would prefer to have a benign uterine disease such as fibroids treated as conservatively as possible. In this context, various complementary and alternative medicine treatments have being used for uterine fibroids in clinical practice. Ayurveda is the most popular complementary medicine in Sri Lankan practice for non-surgical medical treatment of uterine fibroids. The aim of this study is to investigate whether the use of this selected two Ayurveda drug regimens over a period of 12 weeks is able to reduce the size of fibroids and associated features.

Who can participate?
Women aged 18 to 50 with uterine fibroids

What does the study involve?
Participants are randomly allocated to receive one of two Ayurveda treatments for 12 weeks, including oral drugs and external oil application. Volume of the largest fibroid is measured at the start and the end of the study (12 weeks).

What were the possible benefits and risks of participating?
The participants receive information and advice from a specialized medical team. In addition their participation helps to develop an Ayurveda drug treatment for uterine fibroids.

Where is the study run from?
National Ayurveda Teaching Hospital (Sri Lanka)

When is the study starting and how long is it expected to run for?
January 2017 to February 2020

Who is funding the study?
University Grants Commission (Sri Lanka)

Who is the main contact?
Dr Kaumadi Karunagoda
kaumadi@iim.cmb.ac.lk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kaumadi Karunagoda

ORCID ID

http://orcid.org/0000-0002-2283-5629

Contact details

Institute of Indigenous Medicine
University of Colombo
Colombo
0094
Sri Lanka
+94 (0)713881155
kaumadi@iim.cmb.ac.lk

Type

Public

Additional contact

Dr Pathirage Kamal Perera

ORCID ID

http://orcid.org/0000-0003-0337-1336

Contact details

Institute of indigenous Medicine
University of Colombo
Colombo
0094
Sri Lanka
+94 (0)716419072
kamalperera@iim.cmb.ac.lk

Type

Scientific

Additional contact

Prof Hemantha Senanayake

ORCID ID

http://orcid.org/0000-0003-3722-5898

Contact details

Department of Obstetrics and Gynecology
Faculty of Medicine
University of Colombo
Colombo
0094
Sri Lanka

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016/ MPhil- PhD/ 037

Study information

Scientific title

Randomized, single blind, clinical trial to compare the efficacy of selected two Ayurveda herbal regimens on the treatment of uterine fibroids

Acronym

Study hypothesis

Two Ayurveda drug regimes are effective for the treatment of uterine fibroids.

Ethics approval

Ethics Review Committee, Institute of Indigenous Medicine (ERCIIM), University of Colombo, Sri Lanka, Ethics Review Committee, Institute of Internal Medicine, University of Colombo, Rajagiriya, Sri Lanka, Tel: 094112692385, Email: ethicsreviewiim@gmail.com, 03/08/2017, No: ERC 17/68

Study design

Randomized single-blind three-arm clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Uterine fibroids

Intervention

Included participants will be randomly allocated to Arm I and Arm II to receive Ayurveda treatment regimen with oral and external administration for 12 weeks. The drug regimen is the same for the initial 2 weeks, consisting of decoction Panchamooli Laghudrakshadi 30 ml, bd., before meals, chandraprabha 500 mg x 2 pills, bd., after meals and manibadra powder 5 g at night.

Then for the next 10 weeks Arm I will be treated with decoction (Thriphal gugul) 30 ml, bd., before meals, pancha tikta grita gugulu, 500 mg x 2 pills, and krishnajeeraka powder 5 g bd., after meals. 5 ml of Sarshapadi oil will be applied externally to lower abdomen for 7 days after cessation of menstruation.

Arm II will be treated with decoction (Punarnavashtaka) 30ml, bd., before meals, Kanchanara gugulu, 500mg x 2 pills, and Shatapushpa powder 5 g bd., after meals. 5 ml of Nirgundi oil will be applied externally to lower abdomen for 7 days after cessation of menstruation.

Arm III is a control group. They do not receive any intervention but monitoring will carried out by the investigator. Cases who are waiting for myomectomy or hystorectomy for uterine fibroids will be considered as they don't receive medicine in normal clinical setup.

USS was used to determine the primary outcome. Change from baseline in volume of the largest fibroid was measured with TVS/TAS at the end of 12 weeks (Visit 8) and again after one month at follow up (Visit 10). Changes from baseline in the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, effect of therapy according to the Ayurveda body constituent (Prakriti), and changes of the levels of the hormones estrogen (E2) and FSH will be studied by comparing before and after treatment values as secondary outcome measures.

Follow up - participants will be assessed at two-week intervals at the clinic without a drug intervention. Study participants will be followed up for four weeks after the drug administration period every 2 weeks. Associated features will be assessed in each visit and USS will be performed in the last visit (Visit 10).

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Volume of the largest fibroid measured using TVS/TAS at baseline and the end of intervention (12 weeks)

Secondary outcome measures

1. Health-related quality of life measured using Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire at baseline and the end of the intervention (12 weeks)
2. Effect of the drug regimens according to the body constituents (Ayurveda body type) measured using questionnaire at the end of the intervention (12 weeks)
3. Changes of the serum hormone levels; estrogen (E2), FSH measured by serum investigations at baseline and at the end of intervention (12 weeks)

Overall trial start date

30/01/2017

Overall trial end date

01/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women who are in reproductive age between 18 to 50 years
2. Ability to take medication and be willing to adhere to the medication regimen
3. Willing and able to give informed consent
4. Have at least one fibroid (diameter ≥2 cm) confirmed by pelvic ultrasound

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30 participants for each arm

Participant exclusion criteria

1. Women who had used any steroid hormonal therapy for a minimum of 3 months prior
2. Lactating females
3. Menopausal women
4. Under the inclusion age limit
5. Menorrhagia

Recruitment start date

15/02/2019

Recruitment end date

30/12/2019

Locations

Countries of recruitment

Sri Lanka

Trial participating centre

National Ayurveda Teaching Hospital
Cotta road, Borella, Sri Lanka
Borella
0094 /080
Sri Lanka

Sponsor information

Organisation

University of Colombo

Sponsor details

Faculty of Graduate Studies
94
Cumarathunga Munidasa Mawatha
Colombo
0094
Sri Lanka

Sponsor type

University/education

Website

http://www.fgs.cmb.ac.lk

Funders

Funder type

Government

Funder name

University Grants Commission - Sri Lanka

Alternative name(s)

UGC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Sri Lanka

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Kaumadi Karunagoda (kaumadik@gmail.com). Study participant data sheets will not include contact or identifying details. Study data entry and study management systems used by clinical sites will be secured and password protected. At the end of the study, all study databases will be de-identified and archived. Availability of raw data of the study is based on above conditions.

Intention to publish date

30/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes