| CTRI Number |
CTRI/2023/03/050322 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to compare the effects of an Unani Toothpaste with Herbo-mineral Toothpaste in patients with infection of gums that support the teeth |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AAL/PD/UT/RCT/CCRUM/21-22, version 01, 06/02/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No.516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 Arzeena Jabeen |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
Research OPD AmrÄd Al-AsnÄn-o-Litha (Periodontal Diseases), AG Colony Rd, Sunder Nagar
Hyderabad
TELANGANA |
9032519286
aarzu763@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dant-Rakshak (Herbo-mineral Toothpaste)
|
Use sufficient quantity (Paste) of toothpaste for brushing of teeth with Toothbrush |
| Intervention |
Sunoon-E-Musatahkam-E-Dandan (Unani Toothpaste)
|
Use sufficient quantity (Paste) of toothpaste for brushing of teeth with Toothbrush |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy male and non-pregnant female
2. Aged between 18 and 65 years.
3. Willing to give signed written informed consent
4. 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) |
|
| ExclusionCriteria |
| Details |
1. Requirement for prophylactic antibiotic medication,
2. Unable to comply with a study schedule,
3. Untreated caries
4. Periodontitis requiring prompt treatment or
5. Emergency dental treatment,
6. Wearing any kind of oral appliance,
7. History of known allergies
8. Known case of Hemophilia, Low platelet count (thrombocytopenia) and von Willebrand disease (VWD), etc.
9. Known cases of any other acute illness.
10. Known cases of systemic disorders requiring prolonged treatment.
11. Pregnant and lactating women.
12. History of Hypersensitivity to the study drug or any of its ingredients. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
At baseline, 14th day and 28th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline and end of the treatment i.e. after 28days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
09/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 NIPER
Hyderabad 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 the
safety and efficacy of the Unani Toothpaste (SMD) in healthy volunteers. The
SMD has been described in NFUM and its
actions as mentioned are Dafi‘-i-Ta‘affun (antiseptic), Habis-i-Dam (hemostyptic).
It is recommended to use in the conditions like Bakhr al-Fam (halitosis),
Quruh al-Litha (gingival ulcer), Taharruk al-Asnan
(odontoseisis). The SMD is an Unani formulation
containing 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 the
treatment of Bakhr
al-Fam
(halitosis), Quruh al-Litha (gingival ulcer), and Taharruk al-Asnan
(odontoseisis) since long by eminent Unani physicians. Therefore, this study is
undertaken to validate the safety and efficacy of Unani Toothpowder which is a
modified 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 | |