| CTRI Number |
CTRI/2020/04/024436 [Registered on: 01/04/2020] Trial Registered Prospectively |
| Last Modified On: |
22/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Ashrigdhar by a traditional yog (chopchini, muchukunda, marich and sunthi
) |
|
Scientific Title of Study
|
A Pharmaco-clinical evaluation of Madhusnuhi(Smilax Ovalifolia Roxb.) with special reference of ashrigdara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
priyanka galav |
| Designation |
MD scholar |
| Affiliation |
Institue of post graduate teaching and research in Ayurved jamnagar in |
| Address |
Room no-316 P.G.Girls Hostel Ayurvedic college IPGT and RA jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9783683890 |
| Fax |
|
| Email |
priyanka.galav92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof RN Acharya |
| Designation |
prof. and head of Dravyaguna |
| Affiliation |
Institute of post graduate teaching and research in Ayurved, jamnagar GUJARAT |
| Address |
Prof and HOD of Dravyaguna department, Room no-329 institutional building IPGTRA jamnagar, gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9924585855 |
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof RN Acharya |
| Designation |
Prof and HOD of Dravyaguna department |
| Affiliation |
Institute of Post graduate teaching and research in Ayurved, jamnagar GUJARAT |
| Address |
Room no-329 institutional building IPGTRA jamnagar, gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9924585855 |
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of post graduate teaching and research in ayurveda jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of post graduate teaching and research in ayurveda jamnagar |
| Address |
Ayurvedic college , jamnagar Gujarat |
| 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 |
| Priyanka Galav |
Institute of post graduate teaching and research in Ayurveda |
OPD No 10 jamnagar Gujarat
Jamnagar
GUJARAT |
9783683890
priyanka.galav92@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: N938||Other specified abnormal uterine and vaginal bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Madhusnuhi(smilax ovalifolia) 5gm,sunthi(zinziber official)2.5gm,Marich(piper nigram)1.5gm,Muchukunda(pterospermum acerifolium)5gm |
Dose- 5 gm once in a day
Route- Oral administration. |
| Comparator Agent |
Not applicable as study is single arm trial. |
Not applicable as study is single arm trial. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.patients having signs and symptoms of Asridgara(DUB)such as excessive bleeding per vaginum, backaches, pain in lower abdomen and weakness |
|
| ExclusionCriteria |
| Details |
1.age below 18 years
2.chronic cases of >1 years history
3.Bleeding due to erosion, cancer and fibroid
4.Bleeding from the site other than the uterus
5.suffering with systemic disease like Diabetes, Hypertension, Malignsncy, tuberculosis, renal diseases,liver diseases etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of Asridgara (DUB) such as excessive bleeding per vaginum, Backaches, pain in lower abdomen and weakness etc. and as described in Ayurvedic classics. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemoglobin befor and after the clinical trial. |
2 Month. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
20/04/2020 |
| 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
|
Not yet Published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open labelled clinical study will be carried out to assess the role of Madhusnuhi yoga on patients of Asrigdara after getting approval of IEC (Ref no: PGT/7/-A/ethics/2019-20/2593) dated 10.01.2020 Clinically diagnosed 20 cases of Asrigdara among the patients visiting the OPD of PTSR department were supplied with 5 gm of Madhusnuhi yoga for oral administration for a duration for 7 days. The result will be considered as relief in signs and
symptoms of Asridgara (DUB) such as
excessive bleeding per vaginum, Backaches, pain in lower abdomen and weakness
etc. and as described in Ayurvedic classics. |