| CTRI Number |
CTRI/2024/02/062725 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
effect of Nagardi Kwath and Khadiradi Vati in Sheetad |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Nagaradi Kwath Gandoosh and Khadiradi Vati in the management of Sheetad w.s.r. to Gingivitis
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RISHABH DWIVEDI |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7000956701 |
| Fax |
|
| Email |
rishabhdwivedi113@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Arunima Namdeo |
| Designation |
Professor and Head Of Department |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9179832716 |
| Fax |
|
| Email |
arunimasyadav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RISHABH DWIVEDI |
| Designation |
P.G. Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7000956701 |
| Fax |
|
| Email |
rishabhdwivedi113@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Center, Bhopal |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital And Research Centre |
| Address |
Department of Shalakya Tantra first floor room number 1, Mansarovar Ayurvedic Medical College Hospital and Research Center Hinotiya Alam, Kolar road, Bhopal |
| 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 RISHABH DWIVEDI |
Mansarovar Ayurvedic Medical College Hospital and Research Center |
Department of Shalakya Tantra first floor room number 1, Hinotiya Alam, Kolar road, Bhopal
Bhopal
MADHYA PRADESH |
7000956701
rishabhdwivedi113@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional etics committee Mansarovar Ayurvedic Medical College Hospital and Research Center Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: SITADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gaNDUShaH, गणà¥à¤¡à¥‚षः | (Procedure Reference: Sarangdhar Samhita, Procedure details: Gandoosh twice a day)
(1) Medicine Name: Nagaradi Kwath, Reference: Bhavprakash Chikitsa, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadiradi Vati, Reference: Yogratnakar Uttarsthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Procedure | - | gaNDUShaH, गणà¥à¤¡à¥‚षः and medicine | (Procedure Reference: Sarangdhar Samhita , Procedure details: Gandoosh & khadiradi Vati twice a day )
(1) Medicine Name: Nagaradi Kwath and khadiradi vati, Reference: Bhavprakash Chikitsa and Yogratnakar Uttarsthan, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT WITH SIGN AND SYMPTOMS OF SHEETAD ACCORDING TO SUSHRUT SAMHITA |
|
| ExclusionCriteria |
| Details |
1 Patient suffering from other oral cavity diseases or malignancy.
2 Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the effect of Nagradi Kwath Gandoosh and Khadiradi Vati in Sheetad |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Sheetad & gingivitis & to study mode of action of Nagaradi Kwath gandoodh & Khadiradi Vati.
|
2 Weeks |
|
|
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)
|
04/03/2024 |
| 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
|
Total 60 patients will be randomly selected and divided into 3 groups one group will be treated with Nagaradi Kwath Gandoosh, second group will be treated with Khadiradi Vati and third group will be treated with both Nagaradi kwath Gandoosh and Khadiradi Vati and evaluate and compare the effect on sheetad w.s.r to Gingivitis |