| CTRI Number |
CTRI/2025/07/091706 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of kakodumbar phalarasa in the management of asrigdara with special reference to menorrhagia. |
|
Scientific Title of Study
|
Randmised controlled clinical trial to evaluate the efficacy of kakodumbar phalarasa in the management of Asrigdara with special reference to menorrhagia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vd Samruddhi Shivajirao Thombre |
| Designation |
PG scholer MS prasutitantra evum striroga |
| Affiliation |
L.K.R. Ayurvedic Mahavidyala Pg training and Research centre,Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyala,Prasutitantra and striroga department OPD no. 02, P-2,M.I.D.C. area ,Gadhinglaj,Dist-Kolhapur.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9082872351 |
| Fax |
|
| Email |
tsam8553@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd.Suhas Bajirao Thorat |
| Designation |
Reader and guide of Prasutitantra and striroga department |
| Affiliation |
L.K.R. Ayurvedic Mahavidyala Pg training and Research centre,Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyala,Prasutitantra and striroga department OPD no. 02, P-2,M.I.D.C. area ,Gadhinglaj,Dist-Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
vd Samruddhi Shivajirao Thombre |
| Designation |
PG scholer MS prasutitantra evum striroga |
| Affiliation |
L.K.R. Ayurvedic Mahavidyala Pg training and Research centre,Gadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyala,Prasutitantra and striroga department OPD no. 02, P-2,M.I.D.C. area ,Gadhinglaj,Dist-Kolhapur.
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9082872351 |
| Fax |
|
| Email |
tsam8553@gmail.com |
|
|
Source of Monetary or Material Support
|
| daily opd patients of Late Kedari Redekar Ayurvedic Mahavidyala,Prasutitantra and striroga department OPD no. 02, P-2,M.I.D.C. area ,Gadhinglaj,Dist-Kolhapur
pincode-416502
,Maharashtra,India
|
|
|
Primary Sponsor
|
| Name |
LKR Ayurvedic Mahavidyala Pg training and Research centreGadhinglaj |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyala,Prasutitantra and striroga department OPD no.02,P-2,M.I.D.C. area,Gadhinglaj,Dist-Kolhapur-416502 |
| 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 Samruddhi Shivajirao Thombre |
L.K.R. Ayurvedic hospital |
Late Kedari Redekar Ayurvedic Mahavidyala,Prasutitantra and striroga department OPD no. 02, P-2,M.I.D.C. area ,Gadhinglaj,Dist-Kolhapur-416502
Kolhapur
MAHARASHTRA |
9082872351
tsam8553@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyala,Gadhinglaj,Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KAKODUMBAR PHALARASA, Reference: CHAKRADATTA 66/5, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -DURATION IS 5 DAYS FOR 3 CONSECUTIVE CYCLE | | 2 | Comparator Arm (Non Ayurveda) | | - | tranexemic acid | Tranexamic acid is given in the dose of 500 mg BD.
It is used to prevent heavy menstrual bleeding, menorrhagia. It works by slowing the breakdown of blood clots ,which helps to prevent prolonged bleeding.it belongs to class of drug known as antifibrinolytics.medicine is taken by mouth with or without food
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients between the age group 18-45 years.
2.Patients with Pratyatma Lakshanas of Asrigdara like atyadhik raktstrav,angmard,adhoudharshool.
3.Patient having no any systemic disease
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed patients with uterine & pelvic pathology.
2.Diagnosed patient with any serious systemic disorder.
3.K/C/O Abortion/ ectopic pregnancy.
4.Patient taking Anti-coagulation therapy and having any coagulant defects like Thrombocytopenic Purpura
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
the parameters will be noted down before and after treatment.patient will be diagnosed based on symptoms of asrugdara.Explained in Ayurvedic and modern texts.
1.rajastrav avadhi
2.angamard
3.adhoudharshool
4.katishoola
3.rajapraman |
3rd,5th,7th day of 3 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/08/2025 |
| 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 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
|
Asrigdara or Raktapradara specifically as Menorrhagia. It is defined as cyclic bleeding at normal intervals, the bleeding is either excessive in amount [>80ml] or duration [>7 days] or both. Long duration of flow, passage of big clots, use of increased number of thick sanitary pads, pallor and low level of hemoglobin give an idea about the correct diagnosis and magnitude of menorrhagia. Disruption in menstrual cycles can have an adverse effect on the reproductivity of females. It is mainly responsible for iron deficiency anaemia which can significantly impair quality of life and lead to fatigue, shortness of breath and impairments in work performance. This complication needs to be managed appropriately with iron supplements. The prevalence of menorrhagia was 17% in India. In contrast, studies based on self-reported information suggested that approximately 30 % of women of reproductive age were afflicted with heavy menstrual bleeding. Kakodumbar Phalaras with madhu this Yoga is mentioned in the Chakradutta, in context of Pradara rogadhikara. Which contains only Kakodumbar Phala Swarasa taken with the Madhu Anupana. This drug is easily available, easy to take, affordable and cost effective. Therefore, this Yoga will be selected for the management of Asrigdara |