| CTRI Number |
CTRI/2022/10/046166 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Know the Role of Gambhari(Kashmari) and Yashtimadhu in Asrigdara(Dysfunctional Uterine Bleeding). |
|
Scientific Title of Study
|
A Comparative Clinico - Analytical Study of Kashmari Phala Churna And Yashtimadhu Moola Churna in Asrigdara. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhika Kumiya |
| Designation |
MD Scholar |
| Affiliation |
Rishikul Campus, Uttrakhand Ayurveda University,Haridwar |
| Address |
PG Department of Dravyaguna,
Rishikul Campus,
Uttarakhand Ayurveda University,
Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8739923979 |
| Fax |
|
| Email |
drradhikakumiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chandra Singh |
| Designation |
Professor and Head of The Department |
| Affiliation |
Rishikul Campus, Uttrakhand Ayurveda University,Haridwar |
| Address |
PG Department of Dravyaguna,
Rishikul Campus,
Uttarakhand Ayurveda University,
Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411175362 |
| Fax |
|
| Email |
drdcschauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chandra Singh |
| Designation |
Professor and Head of The Department |
| Affiliation |
Rishikul Campus, Uttrakhand Ayurveda University,Haridwar |
| Address |
PG Department of Dravyaguna,
Rishikul Campus,
Uttarakhand Ayurveda University,
Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411175362 |
| Fax |
|
| Email |
drdcschauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Uttarakhand Ayurved University |
| Address |
PG Department of Dravyaguna,
Rishikul Campus,Uttarakhand Ayurveda University,
Haridwar |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Radhika Kumiya |
Gurukul Campus |
Room No.- 10,OPD of Department of Prasuti Tantra Evam Stri Roga,Gurukul Campus,
Uttarakhand Ayurveda University
Hardwar
UTTARANCHAL |
8739923979
drradhikakumiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: Asrigdara (Dysfunctional Uterine Bleeding ), (2) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: Asrigdara (Dysfunctional Uterine Bleeding ), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kashmari(Gambhari) fruit, Reference: Charak Samhita Sutrasthan 25/40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu root, Reference: Charak Samhita Sutrasthan 4/46, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Classical Symptoms of Asrigdara(Aartava Atipravariti,Angmarda,Vedana)
2.Continuous Vaginal Bleeding
3.History of Heavy Vaginal Bleeding
4.Increased Vaginal Bleeding with Irregularities in the Frequency of Menstrual Cycle |
|
| ExclusionCriteria |
| Details |
1. Severe Anemia Patients
2. Systemic Disease - Bleeding
Disorder,Uncontrolled
Diabetes Mellitus,Hypertension,Heart
Disease,Thyroid Dysfunction.
3. Pelvic Disease - Fibroid ,Benign/Malignant
Tumors of Ovary, Sexual Transmitted Disease
4.Others Serious Medical & Surgical ill Patients
5.Patients with Intra Uterine Devices |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Relief in heavy menstrual bleeding.
2.Relief in Irregularities in the
Frequency of Menstrual Cycle.
3.Relief in pain during mensuration.
|
Observation of the patient during treatment for 3 consecutive menstrual cycles and follow up for another 2 consecutive menstrual cycles after completion of the treatment.Total duration is 5 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in menstrual health and reproductive health of women. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/11/2022 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Among the gynecological disorders Asrigdara is one of the most common menstrual bleeding associated with excessive menstrual bleeding with or without intermenstrual bleeding. It is a considerable health care burden for a women and has adefinite effect on her quality of life.In classical texts many preparation have been described for treatment and managment of Asrigdara, among from them ,the present study is a small effort to compare the efficiency of Kasmari(Gambhari ) phala churna and Yashtimadhu moola churna. in Ayurveda these to drugs are explained as hemostatic drugs in many bleeding disorders. |