| CTRI Number |
CTRI/2022/09/045608 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Karpasa Moola & Patra Churna in White discharge |
|
Scientific Title of Study
|
Comparative Pharmacotherapeutic Evaluation of Karpasa (Gossypium herbaceum Linn.) Moola and Patra Churna in Shwetapradara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mira C Khodifad |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital,Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate,
Vadodara
Vadodara
390019
India
-
Vadodara
GUJARAT
390019
India |
| Phone |
7046780569 |
| Fax |
|
| Email |
meerakhodifad125@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Bhogayata |
| Designation |
Associate professor |
| Affiliation |
Government Ayurved College and Hospital,Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate,
Vadodara
Vadodara
390019
India
-
Vadodara
GUJARAT
390019
India |
| Phone |
9909017823 |
| Fax |
|
| Email |
kamals.ayu21c@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushma Rathod |
| Designation |
Reader Class-1 |
| Affiliation |
Government Ayurved College and Hospital,Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate,
Vadodara
Vadodara
390019
India
-
Vadodara
GUJARAT
390019
India |
| Phone |
9426775141 |
| Fax |
|
| Email |
rathodsushma1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate department of Dravyaguna,Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate, vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital Vadodara |
| Address |
Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate,Vadodara-390019 |
| 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 Mira C Khodifad |
Government Ayurved Hospital Vadodara |
OPD Dravyaguna Department Vadodara GUJARAT
Vadodara
GUJARAT |
7046780569
meerakhodifad125@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:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: Shwetapradara, (2) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, (3) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, (4) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: SOMAROGAH/SVETAPRADARAH, (5) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: Shwetapradara, (6) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: Shwetapradara, (7) ICD-10 Condition:N908||Other specified noninflammatory disorders of vulva and perineum. Ayurveda Condition: Shwetapradara, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpasa Moola Churna, Reference: Vrundamadhava, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: 1 Week Follow up | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karpasa Patra Churna, Reference: Aryabhishak, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Tandulodaka), Additional Information: 1 Week Follow up |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Age between 18 to 45 years of female patients
2 Shwetasrava(Yonigata)
3 Yonikandu
4 Katishoola |
|
| ExclusionCriteria |
| Details |
1 Per-vaginal white discharge due to Malignant condition,Cervicitis, cervical erosion & PID
2 Infection like STD
3 Planning for pregnancy
4 Pregnancy
5 Puerperium
6 Disease like DM etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete remission of the major symptoms i.e. Yonigata Shwetasrava (White vaginal discharge) and Yonikandu (vaginal itching) |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in other symptoms like Katishoola (Low backache), Yonigata alpavedana (Mild vaginal pain), Daurbalya (Weakness) |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study has obtained Institutional Ethics
Committee clearance (GAC/VAD/IEC/71/2021, Dated 15
Sept. 2021) and registered
at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2022/09/045608 (Registered
on 16/09/2022). Study type was randomized single blind clinical trial. Selected
patient was randomly derived divided into two groups [18 in group A (Karpasa
Moola Churna) - & 18 in group B (Karpasa Patra Churna)]
out of which total 18 patients in group A and 15 patients in group B had
completed the treatment dose (3gm – 2 time per day before meal) schedule of
internal application. In Group A highly significant result was found in Yonigata
Shwetasrava, Yonikandu, Katishoola, Daurbalya and Angamarda
while significant result was found in Yonipichchhillata and Adhodarashoola.
In Group A highly significant result was found in Yonigata Shwetasrava,
Yonikandu and Angamarda while significant result was found in Katishoola,
Daurbalya and Adhodarashoola. When comparing Group A with Group B
significant result were found in Yonigata Shwetasrava and Yonikandu.
The variations observed in hematological parameters before and after treatment
were statistically non-significant. There is only one patient was observed for
complete remission from Group A, percentage of marked improvement in Group A
and Group B 44.44% and 40% respectively, Moderate improvement percentage in
group A i.e. 50% and 40% in group B, 20% of mild improvement from Group. No
changes result was not found in any group. |