| CTRI Number |
CTRI/2025/07/091188 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pharmaceutico Analytical Study Of Panchawalkal Based Toothpaste And Its Efficacy In The Management Of Krimidant(Dental Caries)In Comparison With Panchawalkal Kwath Kawala In The Age Group 30 To 45 Year |
|
Scientific Title of Study
|
Pharmaceutico Analytical Study Of Panchawalkal Based Toothpaste And Its Efficacy In The Management Of Krimidant(Dental Caries)In Comparison With Panchawalkal Kwath Kawala |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMahesh Ramesh Waghmare |
| Designation |
PG Scholar |
| Affiliation |
Ashwin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Right Wing Ground floor Rasashatra and Bhaishajya Kalpana Department Ashwin Rural Ayurved College and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9922884108 |
| Fax |
|
| Email |
mahesh9922884108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManoj Subhashrao Kulkarni |
| Designation |
HOD |
| Affiliation |
Ashwin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Right Wing Ground floor Rasashatra and Bhaishajya Kalpana Department Ashwin Rural Ayurved College and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9552734227 |
| Fax |
|
| Email |
vdmanoj007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManoj Subhashrao Kulkarni |
| Designation |
HOD |
| Affiliation |
Ashwin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Right Wing Ground floor Rasashatra and Bhaishajya Kalpana Department Ashwin Rural Ayurved College and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9552734227 |
| Fax |
|
| Email |
vdmanoj007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rasashastra Department Room Number 16 Ashwin Rural Ayurved College and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar 413714 India |
|
|
Primary Sponsor
|
| Name |
Ashwin Rural Ayurved College Manchi Hill Sangamner |
| Address |
Ashwin Rural Ayurved College and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrMahesh Ramesh Waghmare |
Ashwin Rural Ayurved College and Hospital Manchi Hill Sangamner |
Rasashastra Department Room number 16 IPD and OPD Ashwin Rural Ayurved college and Hospital Sadvi Preetisudhaji Maharaj Nagar Manchi Hill Ashvi Bk Tal Sangamner Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA |
9922884108
mahesh9922884108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashwin Rural Ayurved College and Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Type: Drug
Other than classical |
Medicine Name: Panchawalkal Based Toothpaste
Reference:NA
Route: Tropical
Doses form:Kalka/Paste
Dose:pea sized Amount
Duration:7 Days
Kal: Morning and Evening
|
| Comparator Agent |
Type:procedure
Procedure Name:Kawala |
(Procedure Reference:Vagbhatta, Dr. Brahmanand Tripathi, Ashtanga Hridaya, Sutrasthana, adhyaya 22nd, Shlok no.11-12, Chaukhamba Sanskrit Pratishthana, Delhi, Reprint 2014, 258.)
Procedure Details: The quantity which can be rolled out in the month is known as Kawala
The procedure of holding any medicated liquid/Kalka dravya in the month to its facilitate capacity for the specific time with allowing inside the month.)
(1) Medicine Name:Panchawalkal Kwath
Reference: Shri Brahmashankar Mishra, Shri Ruplalji vaishya, Bhavaprakasha Nighantu, Vol.1, Nighantu varga, Chaukhambha Sanskrit Bhawan, Varanasi, 12th edition, 2016, 672-677.
Route: Topical
Dose:15 ml
Doses form: Kwath
Duration:7days
Kal: Morning and Evening |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1:The patients were diagnosed on the basis of the signs and symptoms of Krimedanta (dental caries).
2:Patients having age from 30 to 45 years.
3:Patients of both gender,irrespective of their socioeconomical status, education, etc.
|
|
| ExclusionCriteria |
| Details |
1:Patients of age below 30years and above 45 years.
2:Patients having fractured tooth,periodontal abscess andother diseases of oral cavity.
3:Pregnancy, Menopause, Chronic Hormonal diseases like Diabetes Mellitus, hypo/hyperthyroidism, parathyroidism, bone deformities like osteoarthritis, malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Access and compare Efficacy of Panchawalkal Based Toothpaste in the management of Krimedanta in comparison with Panchawalkal Kwath Kawala by using subjective and objective criteria. |
Total duration of medication: 07 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/07/2025 |
| 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
|
These diseases are categorized as Dantaroga, Dantashoola, Krumidanta(dentalcaries),etc.inAyurveda2.ThePathophysiologyof Krumidanta, mainly points towards the vitiated Vata Dosha causing structural deformity at the tooth surface. Further, it combines with plaque to form dental caries, gingival and periodontal diseases. Among the three dosha dominant Vata Dosha makes teeth hollow and damages nerves, the food particles and dirt get accumulated inthis cavity and can damage nerves. This results in bad breath and accumulation of bacteria (small Krumi). Teeth starts paining, becomes black, get swollen, becomes mobile with bleeding gums. This syndrome may be called "Krumidanta." (Dental caries) in Ayurveda3. Symptoms of Krumidanta described in Sushruta Samhita are Dalana / Maharuja / Vedana (toothache), Sheetadanta / Dantaharsha (sensitive teeth), Krishnachidri / Kotha (black caries), Chala danta (mobile), Stravi (pus formation) and Sasanrambho/durgandha yukta Shotha (inflammation with foul smell)4. Ayurvedahasmentionedvariouseightprincipleswhichis knownas‘AshtangaAyurveda’.ItincludesKaya,Balaetc.branchesinwhichRasashastraandBhaishajyaKalpanaVigyanaalsoincluded5. For proper care of teeth, regular use of Kawala, Gandusha Dharana mentioned in Ayurveda and in modern science tooth brushing was described. Rasashastra and Bhaishajya Kalpana includes various pharmaceuticals, analytical and standardization of drugs and its study. In this study, Toothpaste is made up by the help of Panchawalkal and its efficacy in the management of Krumidanta. |