| CTRI Number |
CTRI/2023/07/055180 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
12/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Drakshadi Vati and Durvadi Ghrita matra basti on female menstrual disorder. |
|
Scientific Title of Study
|
Effect of Drakshadi vati orally and Durvadi ghrita matrabasti
on Pittaja artava dusti- an Exploratory study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAHKASHAN NOOR USMANI |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita vihar,
Fourth floor Academic block, Stri Roga evum Prasuti Tantra Department.
South
DELHI
110076
India |
| Phone |
7302305728 |
| Fax |
|
| Email |
kahkashannoor3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata kadam |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Fourth floor, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita vihar
Fourth floor, Academic block,All India Institute of Ayurveda, Gautampuri, Sarita vihar
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata kadam |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Fourth floor, Academic block, Stri roga evum Prasuti tantra Department, All India Institute of Ayurveda, Gautampuri, Sarita vihar
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Sarita vihar, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri , Sarita vihar, 110076 |
| 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 |
| Kahkashan Noor Usmani |
All India Institute of Ayurveda |
All India Institute of Ayurveda, Gautampuri , Sarita vihar, 110076
Stri roga evum Prasuti tantra department,
South
DELHI |
7302305728
kahkashannoor3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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: PITTAJA/ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durvadi ghrita, Reference: Rasa tantra sara, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Bhaishajya Kal: 7 Days, Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Drakshadi vati, Reference: Susruta uttar tantra, Route: Oral, Dosage Form: Ghrita, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: 90 Days, Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients suffering from symptoms of Pittaj Artav Dushti.Excreted blood is ho,associated with severe burning sensation and feeling of heat, Dysuria (Pittaj Artava dushti subjects with or without fibroids, polyp, adenomyosis) Patient whose thyroid profile is within normal limits, Patient should be interested and give their consent for the study work.
|
|
| ExclusionCriteria |
| Details |
Malignancy of genital tract, Congenital anomalies of genital tract, Other severe systemic illnes |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of pittaja artava dushti. |
BT (Baseline)
AT (12 week)
FOLLOW UP (4 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in physical parameters of rajas. |
BT (Baseline)
AT (12 weeks)
Follow up (4 weeks ) |
| change in physical parameters of raja |
Bt
AT |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
According to doshik predominance sign and symptoms in the patients can be seen. therefore proper knowledge of raja is very much important for planning specific treatment of menstrual disorders according to doshas. as there is no work done on pittaja artava dushti this study will help for planning different treatment modalities for pittaja artava dusti for promising results. |