| CTRI Number |
CTRI/2024/06/068515 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of Yashtimadhu Churna with Madhu Pratisarana in the management of Upakusha with special reference to Plaque Gingivitis
|
|
Scientific Title of Study
|
A randomized open label controlled clinical study to evaluate the efficacy of Yashtimadhu Churna with Madhu Pratisarana in the management of Upakusha with special reference to Plaque Gingivitis
|
| 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 Samhitha S |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9482184354 |
| Fax |
|
| Email |
samhithahegde1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha Kumari B |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9480056218 |
| Fax |
|
| Email |
ayurgeeta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha Kumari B |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9480056218 |
| Fax |
|
| Email |
ayurgeeta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Samhitha S |
| Address |
Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082 |
| Type of Sponsor |
Other [Self] |
|
|
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 Samhitha S |
Sri Sri college Of Ayurvedic Science And Research Hospital |
Room number 305 Department of PG Studies in Shalakyatantra Sri
Sri College of Ayurvedic Science and Research Hospital 21st KM
Kanakapura main road Udayapura post Bengaluru 560082
KARNATAKA
560082
Bangalore Rural
KARNATAKA |
09482184354
samhithahegde1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K050||Acute gingivitis. Ayurveda Condition: UPAKUSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | STOLIN GUM PAINT | Combination of tannic acid, zinc chloride, and cetrimide.
Route: Topical, Dosage form: Gum paint, Dose - 3drops, Frequency - bd, Duration - 7days
followed by gargling with warm water | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: YASHTIMADHU CHURNA WITH MADHU, Reference: Ashtanga hridaya. Uttara tantra. 22/31, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: FOLLOWED BY GARGLING WITH WARM WATER |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 21-40 years irrespective of gender, occupation, religion and socio- economic status.
2.Subjects fulfilling the diagnostic criteria.
3.Subjects willing to undergo trial and sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of Periodontitis.
2.Diagnosed cases of Endocrine disorders, Immune deficiency disorders and Malignant conditions.
3.Subjects with Systemic diseases.
4.Pregnant and lactating women.
|
|
|
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 |
1.Significant improvement in the signs and symptoms of Upakusha.
2.Significant improvement in the gingival healing, assessed based on gingival index.
|
Pre-assessment- 0th day
Post-assessment- 7th day
1st follow up- 14th day
2nd follow up-21st day
Final assessment- 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Generation of in depth analysed data on the different aspect of the disease.
2.Generation of data on possible unexpected drug reaction.
|
Pre-assessment- 0th day
Post-assessment- 7th day
1st follow up- 14th day
2nd follow up-21st day
Final assessment- 30th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2024 |
| 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="2"
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
|
Upakusha is one among the Dantamoolagata roga (Periodontal diseases), caused by Pitta and Rakta dushti characterized by Paaka, Raktasrava, Shotha, Daha, Manda Vedana, Poothi mukha. The signs and symptoms of Upakusha can be considered to those of Gingivitis. A huge population of people are suffering from gingivitis because of unhealthy lifestyle. The most common cause of Gingivitis is poor oral hygiene that results in the formation of plaque on teeth, causing inflammation of the surrounding periodontal tissues and causes the gums to bleed easily. If Plaque gingivitis is neglected and left untreated it may progress to Periodontitis which involves the deeper structures of periodontium. Hence prevention and control of plaque gingivitis at the earliest is essential. In Ayurveda, an effective procedure like Pratisarana has been explained to combat Mukha rogas. Pratisarana means to rub or gently massage with the tip of the finger for a short duration. It helps to bring about Mukhashuddhi , Samyak Lalasrava, Samyak Gandhajnana. It helps in eliminating the main causative factors of the disease by exerting mechanical pressure on the gingiva in the direction of sulcus which removes the food debris, plaque, inflamed granulation tissue and bacterial colonization. RESEARCH QUESTION: Whether Yashtimadhu Churna with Madhu Pratisarana is effective in the management of Upakusha w.s.r to Plaque Gingivitis? HYPOTHESES : Null Hypothesis(H0) : There is no significant difference in clinical efficacy of Yashtimadhu Churna with Madhu Pratisarana and Stolin gum paint in the management of Upakusha w.s.r to Plaque Gingivitis. Alternative Hypothesis(H1) : The clinical efficacy of Yashtimadhu Churna with Madhu Pratisarana is better than Stolin gum paint in the management of Upakusha w.s.r to Plaque Gingivitis. Alternative Hypothesis(H2) : The clinical efficacy of Stolin gum paint is better than Yashtimadhu Churna with Madhu Pratisarana in the management of Upakusha w.s.r. to Plaque Gingivitis. |