| CTRI Number |
CTRI/2025/02/081319 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effectiveness of shuntiparpataka kashaya and chlorhexidine ADS 0.2% mouthwash in plaque induced gingivitis. |
|
Scientific Title of Study
|
Effectiveness of shunti parpataka kwatha gandoosha in comparison with chlorhexidine ADS 0.2 percent mouthwash in plaque induced gingivitis in the age group of 18-60 years -an open label randomised non-inferirity 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 |
Anisha Jayan |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College,Kannur |
| Address |
Department of Shalakyatantra
Government Ayurveda College
Pariyaram
Kannur
kerala
Kannur
KERALA
670503
India |
| Phone |
9207874869 |
| Fax |
|
| Email |
dranishachinchu98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambili k |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College,Kannur |
| Address |
Department of Shalakyatantra Government Ayurveda College
Pariyaram
Kannur
kerala
Kannur
KERALA
670503
India |
| Phone |
9446028794 |
| Fax |
|
| Email |
amlikavinal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anisha Jayan |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College,Kannur |
| Address |
Department of Shalakyatantra
Government Ayuveda College
Pariyaram
Kannur
Kerala
Kannur
KERALA
670503
India |
| Phone |
9207874869 |
| Fax |
|
| Email |
dranishachinchu98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayuveda College
Pariyaram
Kannur
Kerala
India
670503 |
|
|
Primary Sponsor
|
| Name |
Anisha Jayan |
| Address |
Government Ayurveda College
Pariyaram
Kannur
Kerala
India
670503 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Anisha Jayan |
Government Ayurveda College,Pariyaram,Kannur |
Department of Shalakyatantra
Goverment Ayurveda College
Pariyaram
Kannur
Kannur
KERALA |
9207874869
dranishachinchu98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Government Ayurveda College,Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: UPAKUSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine ADS 0.2% | Chlorhexidine ADS 0.2% will be purchased from Dr. Reddy’s pharmaceutical
company
After brushing use 10 ml chlorhexidine ADS O.2 % mouthwash and swish vigorously,
for 1 minute twice daily for 21 days. | | 2 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Ashtangahrdaya, Procedure details: Participants will be asked to hold their mouths full of lukewarm Shunti parpataka
kwatha after brushing. They are advised to keep the chin slightly elevated while doing
so.
• It would be retained till the patient feels his or her mouth filled with mucus or there are
secretions from the nose and eyes.
• Then spit it out of the mouth.
• The procedure is repeated twice daily for 21 days.)
(1) Medicine Name: Shundiparpataka kashayam, Reference: Yogaratnakara, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with Plaque-induced gingivitis with stages 1,2,3.
Participants irrespective of gender within the age group of 18-60 years.
Participants with a minimum of twenty teeth in the oral cavity. |
|
| ExclusionCriteria |
| Details |
Participants with smoking habits.
Participants have taken anticonvulsants immunosuppressants and calcium channel
blockers in the past one month.
Participants have taken Antibiotics in the past one month.
Participants having uncontrolled diabetes (FBS greater than 110 mg percent and PPBS greater than 140 mg percent)
Orthodontic and prosthetic appliances use.
Participants with cardiovascular diseases hemorrhagic disorders and leukemia.
Participants who are mentally compromised and bedridden.
Vit C deficiency.
Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Turesky modification of Quigley -Hein Plaque index score in plaque-induced gingivitis stage 1,2,3. |
At baseline,22nd and
35th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing Silness & Loe Gingival index score in plaque induced gingivitis stage 1,2,3. |
At baseline,22nd day & 35th day. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
27/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/12/2025 |
|
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)
|
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)
|
Gingivitis is the most common form of gingival disease. It is characterized by inflammation of the gum, spontaneous bleeding redness, and halitosis. Gingivitis is reversible, but if left untreated it can progress into periodontitis. The most common cause of gingivitis is poor oral hygiene leading to plaque formation on teeth. Sheetada is one among the dantamoolagatha roga caused by vitiation of kapha and rakta exhibit the similar feature of gingivitis. Sheetada chikitsa involves rakthamokshana, pralepana, nasyam, kavala, and gandusha. This study explores the potential of traditional Ayurvedic practice against the conventional treatment method. An open-label randomised controlled clinical trial with 38 participants satisfying inclusion criteria was selected from the OPD of Shalakyatantra Department of Govt. Ayurveda College Kannur. They were assigned to a trial group with Shunti parpataka kwatha twice daily and a control group with chlorhexidine ADS 0.2 % twice daily. The outcome of the study was statistically analyzed based on the change in plaque index score and gingival index score from the baseline on the 22nd day and in the follow-up on the 35th day. Both the trial and control groups showed stastically significant reduction in the gingival index and plaque index scores following treatment and during follow up. (p<0.001). |