| CTRI Number |
CTRI/2024/03/064531 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study for use of Rubia Cordifolia (Manjistha) for treatment of gum disease |
|
Scientific Title of Study
|
A comparative evaluation of the efficacy of systemically and locally delivered Rubia cordifolia (Manjistha) as an adjunct to scaling and root planing in generalized moderate to severe chronic periodontitis patients – A Randomized Controlled Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranav Kudale |
| Designation |
Postgraduate student |
| Affiliation |
Govt. Dental College and Hospital Mumbai |
| Address |
215, Department of Periodontology, Govt. Dental College and Hospital, St. George’s Hospital campus, Fort, Mumbai.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8308788701 |
| Fax |
|
| Email |
kudalepranav51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Gaikwad |
| Designation |
Professor |
| Affiliation |
GDCH, MUMBAI |
| Address |
215, Department of Periodontology, Govt. Dental College and Hospital, St. George’s Hospital campus, Fort, Mumbai.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranav Kudale |
| Designation |
Postgraduate student |
| Affiliation |
GDCH, MUMBAI |
| Address |
215, Department of Periodontology, Govt. Dental College and Hospital, St. George’s Hospital campus, Fort, Mumbai.
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8308788701 |
| Fax |
|
| Email |
kudalepranav51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Pranav Kudale |
| Address |
215, Department of Periodontology, Govt. Dental College and Hospital, St. George’s Hospital campus, Fort, Mumbai. |
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 |
| Dean Government Dental College and Hospital St Georges Hospital campus Fort Mumbai |
Govt. Dental College and Hospital, Mumbai |
215, Department of Periodontology, Govt. Dental College and Hospital, St. George’s Hospital campus, Fort, Mumbai.
Mumbai
MAHARASHTRA |
226206681
deangdch_mumbai@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: dantaveshtakah, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo mouthwash | | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rubia cordifolia, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Rubia cordifolia, Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patients with generalized moderate to severe chronic periodontitis (Greater than 3 mm of Clinical Attachment Loss), according to 1999 International workshop for the classification of 1. the periodontal diseases organized by the American Academy of Periodontology (AAP).59
2. Patients in age group of 21 - 60 years of either sex,
3. Patients with at least 20 natural teeth,
4. Patient ready to give written informed consent. |
|
| ExclusionCriteria |
| Details |
• Medically compromised patients,
• Patients on antibiotic or antimicrobial therapy in the past 6 months,
• Smokers and smokeless tobacco users,
• Patients who have received periodontal treatment in the past 6 months,
• Pregnant women and lactating mothers,
• Patients allergic to any material used in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GINGIVAL INDEX, PLAQUE INDEX, PROBING POCKED DEPTH REDUCTION |
1 week, 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CLINICAL ATTACHMENT LOSS |
1 WEEK 1 MONTH |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/05/2024 |
| 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 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
|
Patients having moderate to severe chronic periodontitis will be assigned randomly into 4 groups and will be given Rubia cordifolia mouthwash, capsules and placebo mouthwash according to the groups. Baseline records will be taken and scaling and root planing will be performed. Upon completion of scaling and root planing patint will be given above mentioned interventions according to their groups. then patient will be assesed at 1 week and 1 month interval and measurement will be recorded for plaque index, gingivl index, probing pocket depth, clinical attachment loss and then results will be drawn and published. |