| CTRI Number |
CTRI/2025/12/099068 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
clinical study of raktavisravanottar kanadya churna pratisarana in dantaveshtaka(periodontitis) |
|
Scientific Title of Study
|
Randomized open labelled controlled clinical study of efficacy of raktavisravanottar kanadya churna pratisarana in dantaveshtaka with special reference to periodontitis |
| 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 Shital Rajkumar Meshram |
| Designation |
Assistant Professor Shalakyatantra |
| Affiliation |
|
| Address |
Opd of Shalakyatantra 25 number opd, Government Ayurved college and hospital vazirabad nanded
Dr. Rajendra gode ayurved college and hospital Mardi road Amravati
Amravati
MAHARASHTRA
431601
India |
| Phone |
8956856056 |
| Fax |
|
| Email |
shitalrm1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kalpana S. Wakode |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Opd(25no.) of Shalakyatantra, Government Ayurved college and hospital vazirabad nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9421757613 |
| Fax |
|
| Email |
kalpanawakode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shital R. Meshram |
| Designation |
Assistant Professor shalakyatantra |
| Affiliation |
|
| Address |
OPD No. 25 Government Ayurved college Vazirabad Nanded pincode 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
8956856056 |
| Fax |
|
| Email |
shitalrm1992@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shital Rajkumar Meshram |
| Address |
OPD no 25 Shalakyatantra Government Ayurved college and Hospital vazirabad Nanded 431601 |
| Type of Sponsor |
Government 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 |
| dr Shital Meshram |
Government Ayurved College Nanded |
Opd no. 25 shalakyatantra, Vajirabad Nanded 431601
Nanded
MAHARASHTRA |
8956856056
shitalrm1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Government Ayurved College, Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: DANTAVESHTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: jeerakadya churna, Reference: yogratnakar dantamulgat chikitsa, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -Sthanic Raktavisranana by multiple pricking by needle no 24 follwed by jeerakadya churna pratisarana twice in a day for 21 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kanadya churna, Reference: yogratnakar dantamulgat chikitsa shlok no 15 page no 754, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -sthanik raktavisravan by multiple pricking by needle no 24 followed by kanadya churna pratisarana twice in a day for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Dantaveshtaka.
Shotha (Inflammation of margins and or Gums)
Puyasrava (Pus discharge from the Gums)
Raktasrava (Bleeding from the Gums)
Chaladanta (Moveable tooth)
16 - 60 Years of age.
Patient of either Gender.
Irrespective of socioeconomic Status.
|
|
| ExclusionCriteria |
| Details |
Acute/severe Systemic/oral diseases
Sensitive to local anaesthetic agents.
Tooth malocclusion/ Badly carries tooth.
Use of analgesics/ antibiotics in last one week.
Bleeding disorders, severe anaemia
Patients on drugs which may cause gingival hypertrophy.
Patient is not willing for treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
efficacy of trial drug on periodontitis on assesment criteria-Complete Improvement
Moderate Improvement Mild Improvement
Unchanged
|
22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of raktavisravanottar kanadya churna pratisaran with raktavisravanottar jeerakadya churna pratisaran |
22nd day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="3"
Months="0"
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
|
Null Hypothesis There is no role of Raktavisravanottar Kanadya Churna Pratisarana twice in a day morning and evening for 21 Days in the management of Dantaveshtaka. Alternative Hypothesis H1 Raktavisravanottar Kanadya Churna Pratisarana twice in a day morning and evening for 21 days is significantly effective in the management of Dantaveshtaka. Alternative Hypothesis H2 Raktavisravanottar Kanadya Churna Pratisarana twice in a day(morning and evening) for 21 days is significantly better than Jeerakadya churna twice in a day morning and evening for 21 days in the management of Dantaveshtaka.
Selected 200 patients will be randomly distributed into two equal groups each comprising 100 patient. Group will be named as Group A and Group B. Group A will be Trial Group Group B will be Control Group 1) Trial Group Randomly selected 100 patients will be treated with Sthanik Raktavisravana on 1st day followed by Kanadya Churna Pratisarana twice in a day for 21 days. 2) Control Group Randomly selected 100 patients will be treated with Sthanik Raktavisravana on 1st day followed by Jeerakadya Churna Pratisarana twice in a day for 21 days. Each patient included in the study will be given treatment for 21 days. Follow up on 7th 14th 22nd day of the study Study will be carried out in 3 years duration of PhD. On each step data will be recorded observation from statistical analysis. |