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CTRI Number  CTRI/2024/07/070633 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 03/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Prachchhana karma and Lodhradi Pratisarana alomg with chanadani kwatha orally in the treatment of Dantaveshta(periodontits)  
Scientific Title of Study   to evaluate the efficacy of prachchhana karma and lodhradi pratisarana with and without adjuvant drug chandanandi kwatha orally in the treatment of dantaveshta w.s.r. to periodontitis – an open label randomised comparative clinical 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  Roshni F Patel 
Designation  P.G Scholar 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  OPD NO 3, Department of Shalakya tantra, Government Akhandanad Ayurveda college, Bhadra Ahmedabad, Gujarat, 380001, India.

Ahmadabad
GUJARAT
380001
India 
Phone  8758141571  
Fax    
Email  patelroshni1160@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Kundan Patel  
Designation  Assistant professor 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  OPD NO 3, Department of Shalakya tantra, Government Akhandanad Ayurveda college, Bhadra Ahmedabad, Gujarat, 380001, India.

Ahmadabad
GUJARAT
380001
India 
Phone  9429489015  
Fax    
Email  drkundan14@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vd Kundan Patel  
Designation  Assistant professor 
Affiliation  Government Akhandanand Ayurved College and Hospital 
Address  OPD NO 3, Department of Shalakya tantra, Government Akhandanad Ayurveda college, Bhadra Ahmedabad, Gujarat, 380001, India.

Ahmadabad
GUJARAT
380001
India 
Phone  9429489015  
Fax    
Email  drkundan14@yahoo.com  
 
Source of Monetary or Material Support  
Government Akhandanad Ayurveda college, Bhadra Ahmedabad, Gujarat. 
 
Primary Sponsor  
Name  Government Akhandanand Ayurved College 
Address  Government Akhandanad Ayurveda college and hospital, Bhadra Ahmedabad, Gujarat, 380001, India. 
Type of Sponsor  Government medical college 
 
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 Roshni F Patel  Government Akhandanand Ayurved College and Hospital  OPD NO 3, Department of Shalakya tantra, Government Akhandanad Ayurveda college, Bhadra, Ahmedabad, Gujarat, 380001, India.
Ahmadabad
GUJARAT 		 8758141571

patelroshni1160@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K056||Periodontal disease, unspecified. Ayurveda Condition: DANTAMULAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pracCAnam, प्रच्छानम् (Procedure Reference: shushruta sutra sthan 8/16-17, Procedure details: prachhan karma with parijat patra at dantmoola pradesh. duration: once on starting treatment.)
(1) Medicine Name: lodhradi churna, Reference: shushruta chikitsa sthan 22/14, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 30 Days
(2) Medicine Name: chandanadi kwath, Reference: yogratnakar raktapitta chikitsa 23/36, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 30 Days
2Comparator ArmProcedure-pracCAnam, प्रच्छानम् (Procedure Reference: shushruta sutra sthana 8/16,17, Procedure details: Prachhana karma with parijata patra at dantmoola pradeshe duration - once on starting of treatment)
(1) Medicine Name: lodhradi churna , Reference: shushruta chikitsa sthana 22/14, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Patients having signs and symptoms of Dantaveshta
- Bleeding from gums (Raktasrava)
- Pus discharge from gums (Puyasrava)
- Halitosis (Daurgandhya)
- Tooth Mobility (Chaladanta)
- Discoloration of gums (Krishanata)
- Pain (Vedana)
- Gingival inflammation (Shotha)
- Clinical Attachment loss (CAL) ≥ 3mm
- Probing Pocket Depth (PPD) ≥ 3mm
 
 
ExclusionCriteria 
Details  1.Patient below 18 and above 60 years of age.
2.Patient not willing for trial.
3.Pregnant lady/ lactating mother.
4.Severe dental complications like dental sinus, fractured tooth etc.
5.Medical conditions like AIDS, Bleeding disorders, Cancer, Uncontrolled Diabetes on the basis of clinical history.
6.Medications that affect disease condition like Chemotherapy, Radiotherapy, Steroids etc. on the basis of clinical history.
7.3rd degree of tooth Mobility.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce the symptoms of dantaveshta.  30 days. 
 
Secondary Outcome  
Outcome  TimePoints 
To improve quality of life.  30 days. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) 20/11/2025 
Date of First Enrollment (Global)  01/08/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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)  
In  Mukharoga, Aacharya Sushruta has explained about Dantaveshta. It occurs due to vitiated Rakta accumulated in Dantaveshta (Gum) and gives rise to Raktasrava and Puyasrava   (Bloody and purulent discharge) from gums and loosening of teeth. Based on signs and symptoms described by allopathy science, the disease ‘Dantaveshta’ can be included under the broad heading of periodontitis. 
One of the most noted complications of periodontal disease is tooth loss. Lacunae in modern treatment modalities are post operative pain, bleeding, root hypersensitivity, delayed  healing, taste changes etc.

In Ayurveda, local as well as systemic factors are also addressed, so recurrence can be reduced and other complications may also be prevented.

In Sushruta Samhita, Raktamokshana and Pratisarana has been described for the treatment of Dantaveshta. Acharya Yogratnakara mentioned the treatment of Dantaveshta similar to Raktapittahara. Rakta and Pitta are closely related entities, They tend to mutually contaminate each other. Chandanadi Kwatha is mentioned in the treatment of Raktapitta. Majority of drugs having the property of Pitta Shamaka and Rakta Prasadaka. So Chandanadi kwatha is selected here.

 As per the scholar’s knowledge, no work has been carried out on Raktapittahara Chikitsa for Dantaveshta to address Dushtashonita. Hence Considering the global and national burden of disease periodontitis, its grave complications and limitations in the allopathy science, this study has been taken for current research work. 

Considering all these facts, this study has been planned to evaluate the efficacy of Prachchhana Karma and Lodhradi Pratisarana with and without adjuvant drug Chandanadi Kwatha orally in the treatment of Dantaveshta w.s.r. to periodontitis.

 
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