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 Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 1.Significant improvement in the signs and symptoms of Upakusha.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 40.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.Significant improvement in the signs and symptoms of Upakusha.
Time Frame: Pre-assessment- 0th day | Post-assessment- 7th day | 1st follow up- 14th day | 2nd follow up-21st day | Final assessment- 30th day
2.Significant improvement in the gingival healing, assessed based on gingival index.
Time Frame: Pre-assessment- 0th day | Post-assessment- 7th day | 1st follow up- 14th day | 2nd follow up-21st day | Final assessment- 30th day
Secondary Outcomes
- 1.Generation of in depth analysed data on the different aspect of the disease.(2.Generation of data on possible unexpected drug reaction.)
Investigators
Dr Samhitha S
Sri Sri College Of Ayurvedic Science And Research Hospital