| CTRI Number |
CTRI/2024/12/078002 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to determine the effect of Atibala churna in the management of Raktpradara that is abnormal uterine bleeding |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO DETERMINE THE EFFECT OF ATIBALA CHURNA (ABUTILON INDICUM) IN THE MANAGEMENT OF RAKTAPRADARA W.S.R ABNORMAL 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 |
Dr shabanuri wahid khan |
| Designation |
post graduate resident |
| Affiliation |
Sangam Sevabhavi Trust Ayurved Medical College Sangamner |
| Address |
OPD no 1 Prasuti Tantra and Stri Roga OPD Ground Floor SST Ayurved Medical college Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9892811973 |
| Fax |
|
| Email |
khanshabanuri614@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shabanuri wahid khan |
| Designation |
post graduate resident |
| Affiliation |
Sangam Sevabhavi Trust Ayurved Medical college Sangamner |
| Address |
OPD no 1 Prasuti Tantra and Stri Roga OPD Ground Floor SST Ayurved Medical college Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9892811973 |
| Fax |
|
| Email |
khanshabanuri614@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr amit shinde |
| Designation |
professor |
| Affiliation |
Sangam Sevabhavi Trust Ayurved Medical college |
| Address |
OPD no 1 Prasuti Tantra and Stri Roga OPD Ground Floor SST Ayurved Medical college Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
09881303593 |
| Fax |
|
| Email |
amitshinde112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sangam Sevabhavi Trust Ayurved Medical College Sangamner Dist Ahmadnagar india 422605 |
|
|
Primary Sponsor
|
| Name |
Dr shabanuri wahid khan |
| Address |
sangam sevabhavi trust ayurved mahavidyalaya sangamner ghulewadi dist ahmadnagar 422605 |
| 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 shabanuri wahid khan |
Sangam Sevabhavi Trust Ayurved Medical College |
OPD no 1 Prasuti Tantra and Stri Roga OPD Ground Floor SST Ayurved Medical college Sangamner Dist Ahmadnagar 422605
Ahmadnagar
MAHARASHTRA |
9892811973
khanshabanuri614@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sst ayurved mahavidyalaya 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 | Drug | Classical | | (1) Medicine Name: atibala churna, Reference: bhavprakash madhyam khanda, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu , Reference: sushruta chikitsasthan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
. Patients having symptoms of Raktpradara i.e
1.Raja Ati Pravrutti (Excessive menstrual bleeding i.e more than 3 pads/day).
2.Deergha Kala Artava Pravrutti. (Menstrual bleeding that last for more than 7 days).
3.Daha in Adho Vankshana (Burning sensation in groin region).
4.Shroni, Prushtha and Kukshi shoola (Pain during
menstruation).
5. Hb percentage above 7 gm %. |
|
| ExclusionCriteria |
| Details |
1. Known patients suffering with uterine & pelvic pathology like Uterine fibroid, Adenomyosis, Polyp, Pelvic inflammatory disease, Post-menopausal bleeding, etc.
2. Known patient with any serious systemic disorder like HTM, DM, TB, Thyroid etc.
3. K/C/O Abortion/ ectopic pregnancy.
4. K/C/O PCOD & Other related disease.
5. Patients with IUCD and on OCP pills.
6. Patient taking Anti-coagulation therapy and having any coagulant defects like Thrombocytopenic Purpura. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Atibala Churna in the management of Raktapradara with special reference to Abnormal Uterine Bleeding. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin percentage will be observed |
before treatment & after completion of treatment |
|
|
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 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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
|
Raktapradara is a considerable health care burden for a woman and
has a definite effect on her quality of life. It is said presently only
hormones, prostaglandin synthesis inhibitors (PSI) and antifibrinolytic
agents are available for this condition; these have their own side
effects. AUB leads to loss of productivity and may result in surgical
interventions including hysterectomy. Thus, to overcome above raised problems in present
dissertion study of Atibala Churna is taken in the management of
Raktpradara w.s.r to Abnormal uterine bleeding. Atibala Churna is easily available, cost effective and affordable for
patient. This study is A “RANDOMIZED CONTROLLED CLINICAL TRIAL TO DETERMINE THE
EFFECT OF ATIBALA CHURNA (ABUTILON INDICUM) IN THE
MANAGEMENT OF RAKTAPRADARA W.S.R. TO ABNORMAL UTERINE
BLEEDINGâ€. In this study Randomly 60 patients having signs and symptoms of
Raktapradara will be selected from OPD and IPD of sst Ayurved
Ruganalaya. They will be divided in Group A and Group B accordingly (Group A Trial - Atibala Churna with Madhu, Group B control - Yashtimadhu Churna with Madhu). 30 patients in each group will be studied. study will be conducted in India. Outcome of study will be asses on reducing symptoms of raktapradara like Raja ati pravrutti, deergha kala artava pravruttti, shroni prustha kukshi shoola |