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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  
nil 
 
Primary Sponsor  
Name  Dr Vismaya PV 
Address  Amrita School of Ayurveda,Clappana PO,Kollam, 690525 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K055||Other periodontal diseases. Ayurveda Condition: DANTAMULAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Ashtanga Hridaya,Bhavaprakasha madhya khanda vatadi varga, Procedure details: Pancaksiri vriksa kasaya 70ml 5 minutes twice daily for 30 days)
2Intervention ArmProcedure-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.


 
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