| CTRI Number |
CTRI/2023/07/054875 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Asrigdara [Abnormal Uterine Bleeding] through Ayurveda. |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
| Address |
Room No. 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
| Address |
Room No. 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
| Address |
Room No. 112 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic College and Hospital Kurukshetra, Haryana- 136118 |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
| Address |
Shri Krishna Government Ayurvedic College and Hospital Umri Road Sec 8 Kurukshetra Haryana 136118 |
| Type of Sponsor |
Other [Government Ayurvedic 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 |
| Dr Sudhi Kaushal |
Shri Krishna Government Ayurvedic College and Hospital |
OPD No.15 Department of Prasuti Tantra Evum Stree Roga Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra
HARYANA |
8566806793
kaushalsudhi95@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:N939||Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charka Samhita Siddhi Sathana Chapter 3/16,19, Procedure details: 1. Patient is made to lie in supine postion.
2.Snehan and swedan of abdomen will be done.
3.Patient is made to lie in left lateral position with right leg folded .
4.Matra basti with Balaguduchyadi Taila will be done.
5.After this explusion of oil will be observed.)
(1) Medicine Name: Balaguduchyadi Taila, Reference: Sahasrayogam Taila Prakrana, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab. Tranexamic Acid | Route- Oral Dose- 650mg (2 Tablets) Frequency- TID Duration- 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with either one or all symptoms of Asrigdara like Ritu Atipravitti (excessive bleeding during menstruation), Anritu pravritti (intermenstrual bleeding), Deergha Pravritti (prolonged bleeding).
2. Patients of reproductive, premenopausal age group.
|
|
| ExclusionCriteria |
| Details |
1. Disease beyond the inclusive criteria.
2. Patients with uterine and pelvic pathology like fibroid, Ca cervix, cervical polyp etc.
3. Patients using intrauterine contraceptive device.
4. Bleeding due to Miscarriage, inevitable abortions.
5. Patient with cardiovascular disease.
6. Patients with renal disease.
7. Patients with coagulation disorders.
8. Patients suffering from chronic systemic disease.
9. Patient having bleeding phase more than 15 Days.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.
2.Improvement in Signs & Symptoms of patients.
3. Normalization of menstrual cycle. |
Duration of treatment: It will be given for 3 months.
Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Detailed study of Asrigdara by both ancient & modern view.
2. To find out an Ayurvedic approach for the management of Asrigdara. |
180 Days |
|
|
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)
|
27/07/2023 |
| 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="0"
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
|
Any uterine bleeding outside the normal value, duration, regularity or frequency is AUB. Length of Rituchakra is lunar moon 28 days, normal menstrual interval is 21-35 days, duration of bleeding 3-5 days, amount is 50-80 ml. and change in any of the above parameters is known as Asrigdara. The word Asrigdara explains about prolonged, frequent or excessive menstrual bleeding in Ayurveda. The protocol in treating Asrigdara is to control the excessive bleeding and hence the drugs selected are of mainly madhura-tikta-kashaya rasa and sheeta virya which have Pitta shamaka and stambhaka properties. In our classical texts it is explained that Yoni rogas do not occur without vitiation of Vata, thus first of all Vata should be normalized. So the selected drug will be given in the form of Basti which will help in pacifying Vata Dosha. Keeping all this in mind, this study has been designed to work out the clinical evaluation of effectiveness of Balaguduchyadi Taila matra basti in Asrigdara. There will be two groups of 20-20 patients in which Group A patients will be treated with Balaguduchyadi Taila matra basti. Group B patients will be treated with Tab Tranexamic Acid for three consecutive menstrual cycles. Follow up will be done after every cycle during trial for 3 months. After completing trial of 3 months, patients will be reassessed again after every menstrual cycle for 3 months to check the efficacy of trial drug.
|