| CTRI Number |
CTRI/2024/10/075949 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study of sharpunkha moola churna and bhumyamlaki churna in the management of heavy menstrual bleeding |
|
Scientific Title of Study
|
A comparative clinical study of sharpunkha moola churna and bhumyamlaki churna in the management of 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 Chandrakant Shriwas |
| Designation |
BAMS MD SCHOLAR |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur |
| Address |
New PG Building Department of Dravyagun vigyan Shri
Narayan Prasad Awasthi Goverment Ayurved College Raipur
Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
7089559043 |
| Fax |
|
| Email |
joyatul007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Markam |
| Designation |
Lecturer in department of Dravyagun vigyan |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur |
| Address |
New PG Building Department of Dravyagun vigyan Shri
Narayan Prasad Awasthi Goverment Ayurved College Raipur
Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9340488469 |
| Fax |
|
| Email |
jyoti.markam23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Ghatge |
| Designation |
Professor and HOD Department of Prasutitantra and Striroga |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur |
| Address |
OPD no 16 Striroga and Prasutitantra ground floor Shri Khudadad Dungaji
Govt.Ayurved College and Hospital,Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492001
India |
| Phone |
9407991293 |
| Fax |
|
| Email |
dr.chandrashekhar.ghatge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dravyagun vigyan Shri Narayan Prasad Awasthi Goverment Ayurved College
Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Shri khudadad dungaji government ayurved hospital |
| Address |
Shri Narayan Prasad Awasthi Goverment Ayurved College GE Road
opposite NIT Raipur Chhattisgarh 492010 |
| 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 |
| Dr Chandrakant Shriwas |
Shri Khudadad Dungaji Government Ayurved hospital 492010 |
OPD No 16 Department of Prasutitantra and Striroga
Raipur
CHHATTISGARH |
7089559043
joyatul007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Shri Narayan Prasad Awasthi Goverment Ayurved college Raipur Chhattisgarh |
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 | Drug | Classical | | (1) Medicine Name: Sharpunkha , Reference: Bhaishajya Ratnavali Pradara Chikitsa., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Tandulodaka ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhumyamlaki , Reference: Bhaishajya Ratnavali Pradara Chikitsa., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Tandulodaka ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients having clinical picture of Asrigdara Roga, DUB, Menorrhagia and polymenorrhagia.
Heavy menstrual bleeding with or without regularity of cycle.
The patient having problem of heavy menstrual bleeding for atleast 2 consecutive cycles.
Patients who are prepared to provide consent and patient will be selected irrespective to religion / habitation. |
|
| ExclusionCriteria |
| Details |
Hb % less than 8gms.
Pregnancy and IUCD insertion cases.
Patient suffering from severe systemic uncompensatory disease of Heart/Liver/Kidney etc.
Patient having malignancies.
Patient suffering from uncontrolled DM, HTN.
Patient suffering from uncontrolled endocrinopathy.
Patient suffering from STDs, HIV, HBsAG etc.
Patient suffering from endometrial tuberculosis.
Patient suffering from coagulation disorder.
Patient having bleeding due to miscarriage or abortion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will reduce the symptoms of Asrigdara like excessive menstrual bleeding, weakness, Anemia due to excessive menstrual bleeding, body aches , will cure general weakness |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Will reduce the symptoms of Asrigdara like excessive menstrual bleeding, weakness, Anemia due to excessive menstrual bleeding, body aches , will cure general weakness |
90days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="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
|
In Ayurvedic textbooks, any irregularity in the menstrual cycle that results in heavy and prolonged uterine bleeding is refered to as Asrigdara. Asrigdara is a common gynaecological problem that mimics the dysfunctional form of abnormal uterine bleeding (AUB).
Acharya Sushruta has stated it as Pitta yukta Apan vayu, while Acharya Charaka has stated Asrigdara as Pitta Avrit Apan vayu and Rakhta Pradoshaj vikara.
Keeping all the above mentioned things in mind, due to the need of accessible, cheap and effective treatment for the disease, I have selected the subject of therapeutic and comparative study of Sharapunkha root powder and Bhumyamlaki churna in Asrigdara disease (Menorrhagia), which has been mentioned in Bhaishajya Ratnavali Pradara Chikitsa.
|