| CTRI Number |
CTRI/2025/09/094338 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| 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
|
Kashmaryadikutajaqwatha siddha ghrita and And Ashoka ghrita in Asrigdara wsr To Dysfuntional Uterine bleeding. |
|
Scientific Title of Study
|
AN Open Label Double Arm Comparative Clinical Study TO Evaluate The Efficacy Of Kashmaryadikutajaqwathsiddha ghrita And Ashoka Ghrita In Asrigdara wsr To Dysfuntional Uterine Bleeding. |
| Trial Acronym |
Kashmaryadikutajaqwathsiddha ghrita |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRVILASMATI PATIL |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college and research institute. |
| Address |
Department Of Prasootitantra Evam Streeroga opd no1 and ipd Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi 574118.
Udupi
KARNATAKA
574118
India |
| Phone |
8217525512 |
| Fax |
|
| Email |
patilvilasmati98@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRAMADEVI G |
| Designation |
PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college and research institute hospiatal udupi |
| Address |
Department Pg Scholar Department Of Prasootitantra Evam Streeroga Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi 574118.
Udupi
KARNATAKA
574118
India |
| Phone |
9449937158 |
| Fax |
|
| Email |
dr.ramadevig@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
DRRAMADEVI G |
| Designation |
PROFESSOR |
| Affiliation |
Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi 574118. |
| Address |
Department Of Pg And Phd Studies In Prasutitantra Evam Streeroga Opd No1 And Ipd Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi 574118.
KARNATAKA
574118
India |
| Phone |
9449937158 |
| Fax |
|
| Email |
dr.ramadevig@gmai.com |
|
|
Source of Monetary or Material Support
|
| Dr Vilasmati Patil Pg Scholar Department Of Prasootitantra Evam Streeroga Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi 574118. |
|
|
Primary Sponsor
|
| Name |
DR VILASMATI PATIL |
| Address |
Sri Dharmastala Manjunatheshwara college OF Ayurveda Hospital And Research Centre Kutpady Udupi574118
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR RAMADEVI G |
Sri dharmashtala manjunatheshwara college and research centrehospital udupi Kutpady Udupi574118
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Vilasmati Patil |
Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi |
Department Of Pg And Phd Studies In Prasutitantra Evam Streeroga Opd No1 And Ipd Sri dharmashtala manjunatheshwara college and ayurveda hospital udupi
Udupi
KARNATAKA |
8217525512
patilvilasmati98@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE-HUMAN SDMCAU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N938||Other specified abnormal uterine and vaginal bleeding. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kashmaryadikutajaqwathasiddhaghrita And Ashoka ghrita , Reference: Astang hrdaya ,uttarastana,34th adhyaya, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm milk), Additional Information: 2Months treatment and 1month follow up | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashoka ghrita, Reference: charak chikitsa yonivyapad chikitsa 30th chapter, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: warm milk), Additional Information: 2months treatment and 1 month follow up |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients who has Dysfunctional uterine bleeding with regular or Irregular Menstruation.
2.Patients aged between 16-40years
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any systemic disorders like DM, HTN etc.
2.Patients with any blood coagulopathies.
3. Severe anemia in which HB% is less than 6.5gm%.
4.Patient daignosed with cervical malignancy
5.Patient diagnosed with Adenomyosis, fibroid, other pelvic pathology with organic lesion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare The Effectiveness of Kashmaryadikutajaqwathasiddhaghrita And Ashoka ghrita In asrigdara wsr To Dysfuntional uterine Bleeding. |
2Months Treatment And 1Month Follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bleeding assessment done through FIGO classification & Pictorial Blood loss assessment chart |
2Months Treatment And 1 Month Follow up. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Normal menstrual cycle interval is 28 days
(21-30days)with duration of 4-5days and blood loss 35ml (20-80ml).Any
deviation comes under Dysfunctional uterine bleeding,i.e. excess amount of
bleeding with increased duration or both, expressed in terms of Menorrhagia,
Metrorrahagia, Polymenorrhagia.In Ayurveda,Pradirananaof
Raja named as Pradara and dirana (excessive excretion) of asrkis termed as Asrigdara. Charaka and
Chakrapani say increased rakta gets mixed with Raja, thus the quantity of Raja
increases.Vagbhata explained excessive bleeding during menstrual or
intermenstrual period is considered as main symptom in Asrgdara. Asrgdara appears to be the description of Polymenorrhagia or epimenorrhagia where
there is excessive and prolonged bleeding during menstrual and inter-menstrual
period. In short asrigdara refers to
all types of irregular and Dysfunctional uterine bleedings.DUB i.e. heavy menstrual loss is a common condition
affecting 14-25% of women in their reproductive age and may have a significant
impact on their Physical, Social, Emotional, and Maternal quality of life. Ayurveda got more effective remedies developed from natural drugs since
long time. To promote better treatment, KashmaryadiKutaja Qwath siddhaGhrita
and AshokaGhrita is used which
possess properties like Raktasthambhana
effect and RaktaPittahara effect.
|