| CTRI Number |
CTRI/2024/11/076809 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| 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
|
Ayurvedic management of heavy and prolonged bleeding during menstruation |
|
Scientific Title of Study
|
An open label randomised comparative clinical trial to evaluate the efficacy of Priyangu Ghana Satva and Lajjalu Ghana Satva along with Sadyovirechan in the management of
Asrigdara (Abnormal Uterine Bleeding O and E) |
| 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 Anchal |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b chandigarh 160047 India |
| Address |
Room No. - A-205,Shri Dhanwantry Ayurvedic college and Hospital Sector 46 b Chandigarh India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9915872557 |
| Fax |
|
| Email |
itssharmaanchal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet |
| Designation |
Professor and HOD |
| Affiliation |
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b Chandigarh 160047 India |
| Address |
Room No.205, Department of Prasuti Tantra evam Stree Roga
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b Chandigarh India
Room No.205, Department of Prasuti Tantra evam Stree Roga
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b Chandigarh India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9417039027 |
| Fax |
|
| Email |
harpreet.minni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harpreet |
| Designation |
Professor and HOD |
| Affiliation |
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b Chandigarh 160047 India |
| Address |
Room No.A- 205,Department of Prasuti Tantra Evam Stree Roga
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b Chandigarh India
Room No.A- 205,Department of Prasuti Tantra Evam Stree Roga
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b Chandigarh India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9417039027 |
| Fax |
|
| Email |
harpreet.minni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantry Ayurvedic college and hospital Sector 46 B chandigarh 160047,India |
|
|
Primary Sponsor
|
| Name |
Dr Anchal |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital sector 46 b chandigarh,160047 India |
| Type of Sponsor |
Other [Private Ayurvedic 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 |
| Dr Anchal |
Shri Dhanwantry Ayurvedic College and Hospital sector 46 b Chandigarh India |
Room no 105 1st Floor, Prasuti Tantra evan Stree Roga
Shri Dhanwantry Ayurvedic College and Hospital sector 46 b Chandigarh India
Chandigarh
CHANDIGARH |
9915872557
itssharmaanchal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak Chiktsa, Procedure details: Sadyavirechana will be given 6 days prior to the menstrual cycle,empty stomach for 1 day)
(1) Medicine Name: Trivrit Avleha, Reference: Ashtang Hridya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Priyangu Ghana Satva, Reference: Bhav Prakash, Route: Oral, Dosage Form: Sattva, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: normal water), Additional Information: Medicine will be started 5 days Prior to menstrual
cycle up to 5 days of
menstrual cycle | | 3 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak Chiktsa, Procedure details: Sadyavirechan will be given 6 days prior to the menstrual cycle,empty stomach for 1 day)
(1) Medicine Name: Trivrit Avleha, Reference: Ashtang Hridya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(g), Frequency: od, Duration: 1 Days | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lajjalu Ghana Satva, Reference: Bhavprakash, Route: Oral, Dosage Form: Sattva, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: normal water), Additional Information: Medicine will be started 5 days Prior to menstrual cycle up to 5 days of menstrual cycle |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Subjects having confirm diagnosis of Asrigdara (Abnormal uterine bleeding O and E)
Married and Unmarried Subjects of age group between 20 to 40 years who are willing
to take part in the study
Informed and written consent.
Subjects presenting with at least one of the following features will be included in the
study:
Excessive Bleeding
Prolonged Bleeding |
|
| ExclusionCriteria |
| Details |
AUB P Polyp AUB A Adenomyosis AUB L Leiomyoma AUB M Malignancy AUB C Confirmed Coagulopathy AUB I Iatrogenic Cause
Endometrial Hyperplasia ET more than 11 mm Bleeding due to cervical erosion CA cervix Bleeding following abortion Bleeding due to IUCD Bleeding from any site other than uterus PID Pregnancy Uncontrolled Hypothyroidism Hyperthyroidism Patient taking ATT Endometriosis Diabetes mellitus Hypertension Post-menopausal bleeding Hb less than 8gm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in Amount of Blood Flow
Decrease in Duration of Blood Flow |
from 0th to 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Pain
Increase in Hb% by 1-2% |
from 0th to 90th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="3"
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
|
Abnormal Uterine Bleeding is
defined as bleeding from the uterine corpus which is abnormal in duration,
volume, frequency and/or regularity. In Ayurveda, due to similarity in symptoms
it can be correlated with Asrigdara which is defined as excessive or prolonged
blood loss during menstruation with or without intermenstrual bleeding.To
evaluate and compare the efficacy of Priyangu Ghana Satva and Lajjalu Ghana.Satva
along with Sadyovirechan in normalization of menstrual flow.The trail will be
performed in two groups consisting 30 in each group.One group will be given
Priyangu Ghana Satva along with Sadyovirechana and the second group will receive
Lajjalu Ghana Satva along with Sadyovirechana.The inclusion criteria is Subjects
having confirm diagnosis of Asrigdara (Abnormal uterine bleeding O and E),
Married and Unmarried Subjects of age group between 20 to 40 years who are
willingto take part in the study Informed and written consent.Subjects
presenting with at least one of the following features will be included in the study:
Excessive Bleeding or Prolonged Bleeding and exclusion criteria is AUB P Polyp
AUB A Adenomyosis AUB L Leiomyoma AUB M Malignancy AUB C Confirmed Coagulopathy
AUB I Iatrogenic Cause Endometrial Hyperplasia ET more than 11 mm Bleeding due
to cervical erosion CA cervix Bleeding following abortion Bleeding due to IUCD
Bleeding from any site other than uterus PID Pregnancy Uncontrolled
Hypothyroidism Hyperthyroidism Patient taking ATT Endometriosis Diabetes
mellitus Hypertension Post-menopausal bleeding Hb less than 8gm. The primary
expected outcome are decrease in Amount of Blood Flow and Decrease in Duration
of Blood Flow.Secondary Expected Outcome are Reduction in Pain and Increase in
Hb% by 1-2% |