| CTRI Number |
CTRI/2022/04/042269 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
29/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Priyangu phanta and priyangu taila uttara basti in the management of asrigdara ( dysfuctional uterine bleeding) |
|
Scientific Title of Study
|
Effect of priyangu phanta and priyangu taila uttara basti in the management of asrigdara (d.u.b.) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Sunita Suman |
| Designation |
Professor |
| Affiliation |
Banaras Hindu university |
| Address |
Department of Prasuti tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Prasuti tantra Opd no 24 Ayurveda wing
SSH
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7607165096 |
| Fax |
|
| Email |
ssom18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Sunita Suman |
| Designation |
Professor |
| Affiliation |
Banaras Hindu university |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
BANARAS HINDU UNIVERSITY
Prasuti Tantra Opd no 24
Ayurveda wing
SSH
Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7607165096 |
| Fax |
|
| Email |
ssom18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Varsha |
| Designation |
Junior Resident |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Department Of Prasuti Tantra
Faculty Of Ayurveda
Institute Of Medical Sciences
Banaras Hindu University
Prasuti Tantra Opd no 24
Ayurveda wing
Sir Sunderlal Hospital
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7300227628 |
| Fax |
|
| Email |
varshadhaka95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Ayurveda
Institute of medical sciences
Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institue of Medical Sciences Banaras Hindu University |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sunita Suman |
SSH Banaras Hindu University |
Opd no 24 Prauti Tantra
Ayurveda Wing
Varanasi
UTTAR PRADESH |
7607165096
ssom18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: callicarpa macrophylla, Reference: Charak samhita sutra sthana chapter 4 , Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: oral administration of priyangu phanta 40ml for 3 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: priyanu phanta, Reference: Charak Sutrasthan 4, Route: Oral, Dosage Form: Phanta, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients willing to participate in the research work after giving well informed written
consent, Women between age group 18 to 45 years (all nulliparous and multiparous women) having
all or any signs & symptoms of Asrigdara as Excessive bleeding, Prolonged duration, Intermenstrual bleeding, Other than characteristics of menstrual blood |
|
| ExclusionCriteria |
| Details |
Age below 18 and above 45 years,Bleeding followed by abortion,Bleeding from the site other than the uterus,Any abnormalities detected in investigation ( routine and specific), Coagulation disorders, Patient suffering from chronic systemic diseases like uncontrolled hypertension, uncontrolled diabetes, venereal disease, Thyroid dysfunction, renal diseases, jaundice
or any disorders influencing general physical health and ultimately influencing
menses, Patient using IUCD & OCPs or injectable contraceptives & others, any history of allergy or allergy from trial, Central nervous system disorders like epilepsy, meningitis, migraine or
any other psychological, Respiratory disorders like bronchial asthma, tuberculosis, pneumonia,
pleural effusion, bronchitis, Cardiac disorders like angina, myocardial infarction, congenital
anomaly of heart, Gastrointestinal disorders like appendicitis, cholecystitis, hepatitis,
pancreatitis, cholelithiasis, diverticulitis, gastric ulcer, irritable bowel syndrome &
others,organic pelvic pathology, benign and malignant tumors(Vulval,
vaginal, rectal, cervical, uterine), PID, congenital anomalies of genital tract and
different type of infections of genital, breast carcinoma, Patient is on chemotherapy/ radiotherapy for any malignant condition of any organ. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of prepared proforma and improvement in sign and symptoms of asrigdara
1Average Amount of menstrual blood loss
2 Normal Duration of menstrual blood loss
3 Normal Colour of menstrual blood loss
4 Normal Consistency of menstrual blood loss
5 Relief in Pain in abdomen during menses
6 Relief in Associated symptoms
7 Normal Endometrial thickness
8 Normal Serum Estradiol
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in criteria listed in different scales |
Total four (4) follow-ups will be done at regular interval of one month or as
per duration & interval of her menstrual cycle for 4 consecutive cycles, Three (3) follow ups will be done with medication and one (1) without
medication to see the changes in parameters |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/04/2022 |
| 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="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In today scenario disorder of menstruation is the commonest amongst all the gynecological complaints, which have a direct effect on the physical as well as physiological health of the female ,,Asrigdara is a disease in which excessive and prolonged blood loss during menstruation or even blood loss during intermenstrual period along with different form of normal menstrual blood. Excessive and prolonged bleeding may cause Angmarda (body ache), Dourbalaya (weakness), Daha (burning sensation), Trisha (thirst), Bharama (giddiness), Pralapa (delirium), Panduta (anaemia),Oral use of priyangu Phanta and Uttarabasti with Priyangu taila are one of them which are specific treatment in gynecological and menstrual disorders, All the registered patients will be divided randomly in 3 trial groups ,Group A will be treated with oral administration of Priyangu Phanta (40ml) for duration of 90 days,Group B will be treated with intrauterine instillation of Priyangu Taila (5-15 ml) by Uttara Basti up to 3 days continuously followed by gap of next 3dyas and again administration for next consecutive 3days,Before Uttara Basti, Asthapana Basti will be given for 2days, Group C will be treated with both oral administration of Priyangu Phanta (40ml) for duration of 90 days and Intrauterine instillation of Priyangu Taila (5-15 ml) by Uttara Basti up to 3 days continuously followed by gap of next 3dyas and again administration for next consecutive 3days,Before Uttara Basti, Asthapana Basti will be given for 2days,Total four (4) follow ups will be done at regular interval of one month or as per duration & interval of her menstrual cycle for 4 consecutive cycles,T hree (3) follow ups will be done with medication and one (1) without medication to see the changes in parameters, assessment will be done on the basis of prepared propforma or subjective and objective parameters including improvement in sign and symptoms of Asrigdara |