A Single-Blind, Randomized, Parallel-Group Study to Compare Safety and Efficacy of an Unani Toothpaste with Herbo-mineral Toothpaste in Patients with AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in sign and symptoms of AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases) on the basis of VAS scoring. The bleeding will be scored as per Modified Sulcus Bleeding Index Scoring Criteria.
研究概览
简要总结
This study is designed as a single blind randomized parallel group trial in patients with AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases). Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients enrolled in the study will receive the medicine Sunoon-E-Musatahkam-E-Dandan (Unani Toothpaste)or Dant-Rakshak (Herbo-mineral Toothpaste) as allocated by randomization method. The total duration of treatment will be 28 days and the follow-up for all clinical parameters will be conducted on baseline, 14th and 28th day.
Rationale of study:
The Unani formulation Sunoon-e-Musatahkam-e-Dandan SMD (Unani Toothpowder) was developed into toothpaste by NIPERHyderabad and preclinical safety study of the Unani Toothpaste (Sunoon-e-Musatahkam-e-Dandan) was also carried out by NIPER Hyderabad. This study has been designed to assess thesafety and efficacy of the Unani Toothpaste (SMD) in healthy volunteers. TheSMD has been described in NFUM and itsactions as mentioned are Dafi‘-i-Ta‘affun (antiseptic), Habis-i-Dam (hemostyptic)**.**It is recommended to use in the conditions likeBakhr al-Fam (halitosis),Quruh al-Litha (gingival ulcer), Taharruk al-Asnan(odontoseisis). The SMD is an Unani formulationcontaining herbs and minerals which possess the Dafi‘-i-Ta‘affun (antiseptic),Muhallil Waram (resolvent of inflammation),Mujaffif(desiccant), Muqawwi-i-A‘sab (nervine tonic), Muqawwiyat-i-Asnan-o-Litha (tonics for gums and teeth)*,*Musakkin-i-Alam (analgesic) activities [Anonumous,2006].
The Sunoon-e-Musatahkam-e-Dandan has been in use for thetreatment of Bakhral-Fam(halitosis), Quruh al-Litha (gingival ulcer), and Taharruk al-Asnan(odontoseisis) since long by eminent Unani physicians. Therefore, this study isundertaken to validate the safety and efficacy of Unani Toothpowder which is amodified dosage form of SMD to promote its use in the general public.
Composition of Unani Toothpaste:
| S. No |
Unani Name (scientific name)
Role
Quantity
|1
Mastagi (Pistacia lenticus L.)
Gum/resin
4 parts
|2
Namak-e-Sambhar (Sambhar Lake salt)
Salt
4 parts
|3
Kath Safaid (Acacia leucophloea Willd.)
White catechu
4 parts
|4
Filfil Siyah (Piper nigrum L.)
Seed
4 parts
|5
Azaraqi Sokhta (Strychnos nuxvomica L.)
Seed
4 parts
|6
Shibb-e-Yamani Biryan (Alum)
Roasted alum
4 parts
|7
Tutiya (Copper sulphate)
Blue vitriol
1 part
|8
Sodium Chloride
Salt
TBD
|9
Dicalcium phosphate
Abrasive
TBD
|10
Calcium carbonate
Abrasive
TBD
|11
Glycerin
Humectant
TBD
|12
Gum tragacanth
Thickening agent
TBD
|13
Saccharine
Sweetener
TBD
|14
Sodium lauryl sulphate
Surfactant
TBD
|15
Methylparaben
Preservative
TBD
|16
Propylparaben
Preservative
TBD
|17
Flavoring agent
Flavoring agent
TBD
|18
Distilled water
Solvent
TBD
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and non-pregnant female
- •Aged between 18 and 65 years.
- •Willing to give signed written informed consent
- •Subjects having AmrÄd al-AsnÄn (disease of the teeth) with or without any of the following symptoms: Bakhr al-Fam (halitosis) Quruh al-Litha (gingival ulcer) Taharruk al-Asnan (odontoseisis) Waram al-Lissa (gingival swelling) Humra al-Lissa (gingival erythema) Nazf al-Lisa (gingival bleeding) Dhahab Ma’ al-Asnan (sensitive teeth) Waja‘ al-AsnÄn (toothache).
排除标准
- •Requirement for prophylactic antibiotic medication,
- •Unable to comply with a study schedule,
- •Untreated caries
- •Periodontitis requiring prompt treatment or
- •Emergency dental treatment,
- •Wearing any kind of oral appliance,
- •History of known allergies
- •Known case of Hemophilia, Low platelet count (thrombocytopenia) and von Willebrand disease (VWD), etc.
- •Known cases of any other acute illness.
- •Known cases of systemic disorders requiring prolonged treatment.
- •Pregnant and lactating women.
- •History of Hypersensitivity to the study drug or any of its ingredients.
结局指标
主要结局
Improvement in sign and symptoms of AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases) on the basis of VAS scoring. The bleeding will be scored as per Modified Sulcus Bleeding Index Scoring Criteria.
时间窗: At baseline, 14th day and 28th days.
次要结局
- Haematological and biochemical assessment for safety assessment(At baseline and end of the treatment i.e. after 28days)