| CTRI Number |
CTRI/2024/10/074597 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Gandusha(gargling)and Pratisarana (local medical application) in controlling gum bleeding among patients aged 30-60 years |
|
Scientific Title of Study
|
Effectiveness of Lodradi Pratisarana and Ksheerivriksha
kashaya Gandusha in gingivitis
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Greeshma K U |
| Designation |
PG Scholar, Department of Salakyatantra |
| Affiliation |
Government Ayurveda College , Tripunithura |
| Address |
Department of Salakya tantra ,Government Ayurveda College,Tripunithiura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
8078560792 |
| Fax |
|
| Email |
drgreeshmaku@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreekumar K |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda College , Tripunithura |
| Address |
Department of Salakyatantra
Government Ayurveda college, Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447295858 |
| Fax |
|
| Email |
drsreekumarmsayu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreekumar K |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda College , Tripunithura |
| Address |
Department of Salakyatantra
Government Ayurveda college, Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447295858 |
| Fax |
|
| Email |
drsreekumarmsayu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College,Tripunithura,Ernakulam,Kerala,682301,India |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College, Tripunithura |
| Address |
Government Ayurveda College Tripunithura Puthiyakavu Ernakulam Pincode -682301 |
| Type of Sponsor |
Other [Government Ayurveda College , Tripunithura Ernakulam] |
|
|
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 |
| GREESHMA KU |
Government Ayurveda Medical College Hospital , Tripunithura |
Salakyatantra department, OP number-6,room number-104
Ernakulam
KERALA |
8078560792
drgreeshmaku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA ERNAKULAM 682301 |
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 | Drug | Classical | | (1) Medicine Name: Lodradi choorna pratisarana , Reference: Susrutha samhita, mukharoga chikitsa, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -Topical application on;y | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ksheeri vriksha Kashaya gandusha , Reference: Susrutha samhita, mukharoga chikitsa, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu,gritha,sarkara), Additional Information: -topical application only |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of all genders among the age group of 30-60 yrs. 2. Patients with good glycaemic control 3.Subject having cardinal features of gingivitis namely redness of gums, swollengums, bleeding gums |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating woman
2.Subjects who have undertaken any medications like antibiotics , non-steroidal anti -inflammatory drugs, oral contraceptive pills , antiepileptic drugs, calciumchannel
blockers in the past 3 months.
3. Vitamin C deficiency
4.Subjects underwent oral prophylaxis in the past 6 months
5.Patient under treatment for gingivitis
6. Subjects with inability to comply with the follow up visit.
7. Severe form of gingivitis associated with calculus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the signs and symptoms , changes in the gingival index score and bleeding index score |
Treatment period - 30 days
Assessment will be done on the 0
thday, 8th day,15
th day, 31 st day and after treatment. Followup will be done after 15 days of treatment (46
th day) with gingival assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in the signs and symptoms |
0th day (Before prophylaxis), 8th day, 15th
day, 31st Day and a follow up assessment will be done on 46th day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 |
Date of First Enrollment (India)
Modification(s)
|
26/10/2024 |
| 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="6"
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
Modification(s)
|
A clinical trial with 42 subjects will be selected fromthe OPD of Salakyatantra Department Govt. Ayurveda College Tripunithura based on inclusion and exclusion criteria. Gingival index and bleeding index scoring will be done before intervention. The subjects will be given Ayurvedic management for 30 days. Assessment will be done on 0 th , 8 th , 15 th day and 31 st day and a follow up assessment will be done on 46 th day. A case proforma is created and data will be collected. Outcome of the study will be graded as per the parameters and results will be statistically analysed . |