FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091377 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A comparative analysis of Lata Kasturi (Muskmallow) extract with scaling and root planing for treatment of periodontitis 
Scientific Title of Study   A Comparative Evaluation of Efficacy of Systemically and Locally Delivered Muskmallow (Abelmoschus moschatus) Seed Extracts as an Adjunct to Scaling And Root Planing in Generalized Moderate to Severe Chronic Periodontitis Patients: A Randomized Double Blinded Placebo Controlled 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  Dr Madhu Varma 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital, Chhatrapati Sambhajinagar 
Address  Room no 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar
Near Jain Mandir Road, Darwha, Dist. Yavatmal
Aurangabad
MAHARASHTRA
431001
India 
Phone  7744860111  
Fax    
Email  varmamadhu66@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr C D Dhalkari 
Designation  Professor and Head in Department of Periodontology 
Affiliation  Room no 154, Government Dental College and Hospital, Chhatrapati Sambhajinagar 
Address  Room no 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9422204639  
Fax    
Email  drcddhalkari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr C D Dhalkari 
Designation  Professor and Head in Department of Periodontology 
Affiliation  Room no 154, Government Dental College and Hospital, Chhatrapati Sambhajinagar 
Address  Room no 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar


MAHARASHTRA
431001
India 
Phone  9422204639  
Fax    
Email  drcddhalkari@gmail.com  
 
Source of Monetary or Material Support  
Governmental Dental college and Hospital, Navkhanda, Chhatrapati Sambhajinagar, Maharashtra, India pincode 431001  
 
Primary Sponsor  
Name  Dr. Madhu Varma 
Address  Room no 154, first floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar 
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 Madhu Varma  Government Dental College and Hospital  Room no 154, 1st floor, Department of periodontology, Government Dental College and Hospital, Navkhanda, Chhatrapati Sambhajinagar Near Jain Mandir Road, Darwha, Dist. Yavatmal
Aurangabad
MAHARASHTRA 
7744860111

varmamadhu66@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Dental College and Hospital, Chhatrapati Sambhajinagar, Maharashtra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTAMULAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Muskmallow (Lata Kasturi) , Reference: Dravagun Vidnyan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information:
2Comparator ArmDrugOther than Classical(1) Medicine Name: Tinospora cordifolia , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Tinospora cordifolia is a placebo material inert in nature
3Intervention ArmDrugClassical(1) Medicine Name: Muskmallow (Lata Kasturi), Reference: Dravagun Vidnyan, Route: Topical, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 10ml mouthwash twice daily 30 minutes after brushing for 2 minutes Squish and Spit
4Intervention ArmDrugClassical(1) Medicine Name: Muskmallow (Lata Kasturi), Reference: Dravagun Vidnyan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Combination of Muskmallow Tablets and Mouthwash
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with generalized moderate to severe chronic periodontitis.
2. Patients in age group of 30 - 65 years of either sex.
3. Patients with at least 20 natural teeth.
4. Patient ready to give written informed consent.
5. Systemically healthy patients.
 
 
ExclusionCriteria 
Details  1. Patients on antibiotic or antimicrobial therapy in last 6 months.
2. Smokers and smokeless tobacco users.
3. Patients who have received periodontal treatment in the past 6 months.
4. Pregnant and lactating mothers.
5. Patients allergic to any material used in study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Modified Gingival index
Papillary bleeding Index
Plaque index
Probing pocket depth
Pocket probing depth
Clinical attachment loss
Radiographic evaluation of bone level  
1week
1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical attachment loss
Radiographic evaluation of bone level  
1 week
1 month 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   05/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Oral health is integral to general health and essential for wellbeing. Despite impressive improvements in oral health because of much better oral hygiene maintenance, problems still remain in many places around the world1. Oral cavity is a favourable habitat for a variety of bacteria due to the constant presence of nutrients and secretions. Some bacteria of normal oral flora are pathogenic and cause harm to the host. Many of these organisms are responsible for the formation of plaque which in turn is responsible for diseases like dental caries, gingivitis and periodontitis. Mechanical removal of dental biofilm is a key factor in the prevention of oral diseases. The tools most commonly used in mechanical plaque control are the toothbrushes (manual or electric), floss, woodsticks and interdental brushes11. Despite the availability of various oral hygiene devices, even the most meticulous person will not always completely remove all the plaque. The recognized inadequacies in the mechanical plaque control practices of many individuals has fuelled a year-long search for chemical agents to control plaque.

Chemotherapeutic mouthrinses endow with chemically significant benefit in the reduction of plaque induced gingivitis. Mouthrinses encompass the ability to deliver therapeutic ingredients and benefits to all accessible surfaces in the mouth including interproximal surfaces. They also remain effective for unmitigated period of time depending on their substantivity. Mature, intact biofilms hinder the action of chemotherapeutic agents. Hence antimicrobial agents have to be used adjunctively to scaling and root planing and not as first line of treatment in the management of periodontitis. To date no single chemotherapeutic agent is found to target all pathogens harbouring the periodontal pocket. These limitations force us to use a combination of antimicrobials and a judicious selection of antimicrobials targeting the pathogens is quite essential. But synthetic antimicrobials and anti-inflammatory agent have side effects and result in complications like drug resistance, gastrointestinal complications, congestive heart failures, renal failures, allergic reactions, which may at times be life-threatening. Also there are side effects of various mouthwashes such as tooth and tongue staining, taste alterations, and mucosal erosions that limit patient complianceToday dentists are practicing in an era where the patients are more concerned about their oral health and their overall wellbeing. Thus, in the midst of growing evidence of the connection between oral and systemic health, herbal medicines with their ‘naturally occurring’ active ingredients offer a gentle and enduring solution for restoration of health in a more trustworthy and least harmful way.

Traditional medicine is deep rooted and grounded deep in India and is being used here since times immemorial. Ayurvedic medicine is a system used by Indians and is native to the Indian subcontinent as a form of alternative medicine. It has also attracted much attention in developed countries such as Europe, United States and Japan. Charka samhita and Sushutra samhita have been the basis of ayurvedic medicine since a long time

Rationale

During past two decades reliability and usage of herbal products has assumed increasing importance, due to the side effects and complications of many chemical and synthetic medicines. About 25% of drugs are derived from plants and many other are formed from prototype compounds isolated from plant species. These medicines contain natural phytochemicals in them and offer an effective alternative to antibiotics and represent a promising approach in the prevention and therapeutic strategies for oral infections too. Because of relatively safe nature of herbal extracts, many herbal products and their component are being used for treating periodontitis in the form of local drug delivery as well systemicallyTherefore, the purpose of this study was to evaluate the effects of systemic and locally delivered  Muskmallow (Abelmoschus moschatus) seed extracts as an adjunct to scaling and root planing in patients with generalized moderate to severe chronic periodontitis.

 
Close