| CTRI Number |
CTRI/2025/05/087470 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
EFFECT OF CONSUMING MEDICATED MILK PREPARED WITH HERBS LIKE SATAVARI AND GOKSHURA AND TABLET TRIPHALA GUGGULU IN HEAVY BLEEDING DUE TO NON CANCEROUS GROWTH IN UTERUS |
|
Scientific Title of Study
|
COMBINED EFFECTIVENESS OF SATAVARI GOKSHURA KSHEERAPAKA AND TRIPHALA GUGGULU IN FIBROID WITH HEAVY UTERINE BLEEDING |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Asok |
| Designation |
PG Scholar, Dept of prasutitantra and striroga |
| Affiliation |
Government ayurveda medical college and hospital,Thiruvananthapuram |
| Address |
Government ayurveda college and hospital, Pullimoodu junction Thiruvananthapuram, Kerala
Dept of prasutitantra and striroga ROOM NO:1
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7510718947 |
| Fax |
|
| Email |
archanaasok911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana Asok |
| Designation |
PG Scholar, Dept of prasutitantra and striroga |
| Affiliation |
Government ayurveda medical college and hospital,Thiruvananthapuram |
| Address |
Government ayurveda college and hospital, Pullimoodu junction Thiruvananthapuram, Kerala
Dept of prasutitantra and striroga ROOM NO:1
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7510718947 |
| Fax |
|
| Email |
archanaasok911@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Thomas |
| Designation |
Associate professor,Dept of prasutitantra and striroga |
| Affiliation |
Government ayurveda medical college and hospital,Thiruvananthapuram |
| Address |
Government ayurveda college and hospital, Pullimoodu junction Thiruvananthapuram, Kerala
Dept of prasutitantra and striroga ROOM NO:1
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446485655 |
| Fax |
|
| Email |
gibythomasdr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Archana Asok |
| Address |
PG Scholar,Govt ayurveda medical college and hospital Pulimoodu junction Thiruvananthapuram 695001 Kerala 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 |
| Archana Asok |
Govt ayurveda hospital for women and children Poojapura |
Dept of prasutitantra and striroga, OP NO- 1 Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA |
07510718947
archanaasok911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Govt ayurveda college Thiruvananthapuram, Kerala, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SATAVARI GOKSHURA KSHEERAPAKA , Reference: CHARAKA SAMHITHA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -NIL(2) Medicine Name: TRIPHALA GUGGULU, Reference: YOGARATNAKARA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 40 Days, anupAna/sahapAna: Yes(details: -HOTWATER), Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
45.00 Day(s) |
| Gender |
Female |
| Details |
Participants of age group between 25-45 years sonologically diagnosed with Uterine fibroids of size less than 8 cm and associated with Menorrhagia and Metrorrhagia |
|
| ExclusionCriteria |
| Details |
Fibroids with dysmenorrhea only
Diagnosed case of malignancy
Pregnancy and lactation
Patients with Hb<8gm/dl
Uncontrolled systemic illness
Post menopausal women
Known case of dyslipidemia
Patients with bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in bleeding due to uterine fibroid |
0th day, 31st day ,61st day during study period and on 91st day during follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in size of fibroid |
0th day during study period & 91st day during follow up |
| Change in dysmenorrhea |
0th day, 31st day & 61st day during study period & 91st day during follow up |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="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
|
Uterine fibroids otherwise known as leiomyoma is the non cancerous growth commonly seen in women in the childbearing age. They exhibit wide range of symptoms like dysmenorrhea, pressure symptoms, menorrhagia, metrorrhagia, low back ache etc. However menorrhagia and metrorrhagia is a major burden. The exact correlation of uterine fibroids are not available in our classics and it may be correlated to garbhasayagata mamsagranthi which is caused by tridosa mainly vata and kapha along with vitiated mamsa, rakta and medha. When they are present in garbhasaya it increases the surface are of the endometrial tissue resulting in heavy beeding. The menorrhagia and metrorrhagia which are commonly seen in fibroids and comes with heavy uterine bleeding can be critically reviewed in the context of asrgdara with predominance of rakta and pitta. Hence the treatment protocol befitting the samprarpthi vighatana of asrgdara can be subjected and vata kaphahara and raktapittahara treatment can be adopted here. Hence triphala guggulu mentioned in vidradhi rogadhikara which is tridoshahara, lekhana, medhohara and satavari gokshura ksheerapaka mentioned in raktapitta rogadhikara which is raktapittahara, asrajit is being used in this study. Females in the age group 25 - 45 years having sonologically diagnosed fibroids with menorrhagia and metrorrhagia will be selected from the OPD of prasutitantara and striroga, Government ayurveda college Thiruvananthapuram as per inclusion and exclusion criteria. Participants willbe advised to take 48ml kashaya as ksheerapaka twice daily before food for two consecutive months and 1.5g triphala guggulu tablet twice will be given for 20 days in each month excluding the days of menstruation. Patients will be advised to report on 31st and 61st day during study perod and 91st day for follow up. Outcome variable will be assessed using PBAC score. Changes in secondary objective will be assessed by VAS pain scale and USG. |