| CTRI Number |
CTRI/2025/05/087455 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment of swelling of gums with Mustadi Churna for local application, Scaling (cleaning of tooth with the help of ultrasonic scaler) with and without Raktamokshan (blood letting) |
|
Scientific Title of Study
|
Role of Mustadi Churna Pratisarana and Scaling with and without Raktamokshana(Prachchana Vidhi) in the Management of Shitada(Gingivitis)- An Open Labelled Randomized Comparative 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 |
Apurva Khatri |
| Designation |
M. S. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat |
| Address |
Department of Shalakya Tantra, fourth floor, Institute Building, ITRA, Jamnagar, Gujrat
Jamnagar
GUJARAT
361008
India |
| Phone |
8308504240 |
| Fax |
|
| Email |
apoorvakhatri15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Unadkat |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat |
| Address |
Fourth Floor, Department of Shalakya Tantra, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427242598 |
| Fax |
|
| Email |
drrsunadkat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Apurva Khatri |
| Designation |
M.S. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat |
| Address |
Department of Shalakya Tantra, fourth floor, Institute Building, ITRA, Jamnagar, Gujrat
Jamnagar
GUJARAT
361008
India |
| Phone |
8308504240 |
| Fax |
|
| Email |
apoorvakhatri15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Opposite to B Division Police Station, Gurudwara Road, Jamnagar, Gujrat, India -361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching and Research in Ayurveda, Opposite to City B Division Police Station, Gurudwara Road, Jamnagar, Gujrat, India- 361008 |
| 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 Apurva Khatri |
Institute of Teaching and Research in Ayurveda Hospital |
OPD No. A-4, Dental, OPD of Shalakya Tantra, Institute of Teaching and Research in Ayurveda, Opposite to B Division Police Station, Jamnagar, Gujrat 361008
Jamnagar
GUJARAT |
8308504240
apoorvakhatri15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar |
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 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रक्तमोक्षणम्/ शोणितस्रावः/ अस्रविस्रुतिः/शस्त्रविस्रावणम् | (Procedure Reference: sushrut samhita sutrasthan adhyay 14, Procedure details: Raktamokshan - Prachchan vidhi)
(1) Medicine Name: Mustadi Churna, Reference: Ashtang samgrah uttar tantra adhyay 26, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | Scaling | (Procedure Reference: modern medicine, Procedure details: Scaling with the help of ultrasonoc scaler. First sitting at first day of enrollment and Second sitting after 15 days if required.)
(1) Medicine Name: Mustadi Churna, Reference: Ashtang samgraha uttartantra adhyay26, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of either sex aged between 18 to 60 years of age presenting with signs and symptoms of Shitada(Gingivitis) described as per Ayurveda and Modern Science will be included in the study.
2. The diagnosis of the disease shall be done on the basis of signs and symptoms of Shitada(Gingivitis) i.e. Akasmata Rakta Srav(Bleeding), Shoth(Inflammation), Krishnata(Discoloration of gums), Mukh Daurgandhya(Halitosis), Vedana(Pain), Dantmansa Prakleda(Moistness),Pak(Pus Discharge) and Dantmans Mriduta(Sponginess)
3. Patient having minimum three clinical symptoms of shitada will be included in the study. Primary symptom is Akasmat Rakta Srav(Bleeding) along with any other symptom of Shitada. |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years and more than 60 years of age.
2.Patients with periodontal pocket with pus discharge.
3.Patients with evidence of malignancy, HIV and Diabetes Mellitus.
4.Any systemic disorder which may alter the result of the study i.e. Haemophilia or any other bleeding disorders.
5.Pregnant woman shall be excluded.
6.Patients who are using anticoagulant drugs like Aspirin will be excluded.
7.Patients taking any other systemic drugs which can alter the result of the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of intervention on signs and symptoms of Shitada(Gingivitis) |
During the treatment period of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life of the patient Assessment of recurrence of signs and symptoms of Shitada(Gingivitis) |
During the treatment period of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/06/2025 |
| 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
|
This trial is randomized clinical trial to evaluate efficacy of Mustadi Churna Pratisarana and Scaling with and without Raktamokshana (Prachchana Vidhi) in the management of Shitada(Gingivitis). Total 40 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer based randomization. In the study Mustadi Churna Pratisarana 3gms BD, Scaling and Raktamokshana (Prachchana Vidhi ) will be done in one group. In another group only Mustadi Churna Pratisarana and Scaling will be done for one month without Raktamokshana (Prachchana Vidhi). Follow up will be carried out at 15 days interval for one month after completion of therapy. |