| CTRI Number |
CTRI/2026/04/107753 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| 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 Ayurvedic Herbal Gum Application and Mouth Rinse in Treating Gum Disease in People with Diabetes |
|
Scientific Title of Study
|
COMBINED EFFECT OF YASTYADI PRATISARANA & PANCAKSIRI VRIKSA KASAYA GANDUSA IN DIABETIC PERIODONTITIS-open label single arm study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vismaya PV |
| Designation |
PG SCHOLAR |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda,
Clappano P.O. ,Kollam,
690525
Kollam KERALA 690525 India |
| Phone |
8078277875 |
| Fax |
|
| Email |
vismayarevi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Sivabalaji |
| Designation |
Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda,
Clappano P.O. ,Kollam,
690525
Kollam KERALA 690525 India |
| Phone |
7559027947 |
| Fax |
|
| Email |
balajisiva85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vismaya PV |
| Designation |
PG SCHOLAR |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Amrita School of Ayurveda,
Clappano P.O. ,Kollam,
690525
Kollam KERALA 690525 India |
| Phone |
8078277875 |
| Fax |
|
| Email |
vismayarevi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vismaya PV |
| Address |
Amrita School of Ayurveda,Clappana PO,Kollam,
690525 |
| 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 |
| Dr Vismaya P V |
Amrita Ayurveda hospital |
Department of Shalakya Tantra OPD no.2 Vallikavu P.O. clappana
Kollam 690525 Kollam KERALA |
8078277875
vismayarevi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional ethics Committee Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K055||Other periodontal diseases. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Ashtanga Hridaya,Bhavaprakasha madhya khanda vatadi varga, Procedure details: Pancaksiri vriksa kasaya 70ml 5 minutes twice daily
for 30 days)
| | 2 | Intervention Arm | Procedure | - | pratisAraNam, प्रतिसारणम् | (Procedure Reference: Ashtanga Hridaya, Procedure details: Yasti,sarjakshara,shunti,saindava choorna mixed with honey,650mg ,twice daily ,2 minutes for 30 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
HbA1c greater than 7
GIB with grade 1 and 2 & PI with grade 1 and 2
Age within 35 to 65years of either gender
Chronicity less than 5yrs
Minimum of 3 sites with greater than or equal to 3mm pocket depth
Minimum of 3 sites that bleed on probing
Patients who have not received any periodontal therapies during past 6 months
|
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic diseases like cardiovascular, kidney disorders, Atherosclerosis.
Patients having alveolar bone destruction
Pregnant or lactating females ,Immunocompromised patient, smokers, alcoholics
Patients who received any chemotherapeutic medicines during past 6 months
Patients who are contraindicated for gandusa
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Resolution of Clinical symptoms of Diabetic Periodontitis like pain ,gingival swelling, bleeding of gums, loosening of teeth.
To evaluate the improvement in objective parameters such as plaque index and gingival bleeding index after treatment.
To assess the change in salivary pH levels before and after the treatment.
To determine the effect of treatment on the microbial colony count in saliva, aiming to restore normal oral flora
|
Treatment period Day 1 to day 30
follow up day 45, 60, 75,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in HbA1c level before and after the treatment |
Day 1, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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)
|
20/04/2026 |
| 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 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
|
Diabetic periodontitis is a chronic
inflammatory condition with a bidirectional relationship with diabetes
mellitus, contributing to worsening periodontal destruction and poor glycemic
control. Conventional treatments such as scaling, chlorhexidine mouthwash, and
surgical procedures have limitations including cost, side effects, and
incomplete efficacy in diabetic patients. Previous clinical studies have shown
that Yashtyadi Pratisarana and Pancaksiri Vriksa Kashaya Gandusa are effective
in reducing pain, bleeding gums, discoloration of gums, halitosis, and
microbial load, while improving plaque index, gingival bleeding index, and
salivary pH in periodontitis, but there is a lack of studies in diabetic
populations.
The present study aims to assess whether
administration of Yashtyadi Pratisarana (Yastimadhu, Sarjakshara, Shunti and
Saindhava curna with honey, 650 mg, applied twice daily for 2 minutes) followed
by Pancaksiri Vriksa Kashaya Gandusa (70 ml, held in the mouth for 5 minutes
twice daily) for one month can effectively reduce the clinical symptoms of
diabetic periodontitis and restore normal oral flora as assessed by saliva
culture. Eighteen patients aged 35–65 years with HbA1c >7, plaque index and
gingival bleeding index grade 1–2, and chronicity less than 5 years will be
enrolled from OPD and IPD of Amrita Ayurveda Hospital. Patients with systemic
illnesses, smokers, alcoholics, pregnant or lactating women, and those with
alveolar bone destruction or contraindications to Gandusa will be excluded.
The intervention will be given for 30 days
with follow ups on day 45, 60, 75 and 90. Subjective parameters (pain, bleeding
gums, discoloration of gums, loosening of teeth) and objective parameters
(plaque index, gingival bleeding index, salivary pH, microbial load, HbA1c)
will be assessed before and after treatment. Data will be analyzed
statistically using Wilcoxon signed rank test and paired t test. Improvement in
subjective and objective parameters will be considered as outcome. Informed
consent will be obtained in local language, CTRI registration and IEC approval
will be ensured, and rescue medications will be provided if required. Patients
will be allowed to withdraw in case of adverse effects, worsening symptoms, or
unwillingness to continue. Dropouts will include missed doses, non-compliance,
adverse events, migration, or mortality. This study is expected to provide
evidence for a safe, cost-effective Ayurvedic protocol in managing diabetic
periodontitis and improving oral health outcomes in diabetic patients. |