| CTRI Number |
CTRI/2023/04/051895 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Bleeding piles with Unani medicine Majoon Teewaj |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Majoon Teewaj in BawÄsÄ«r DÄmiya (Bleeding Piles) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BD/BP/MT/CLNVAL/CCRUM /21-22 |
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 Regional Research Institute of Unani Medicine (RRIUM), Patna 2. Clinical Research Unit (CRU), Meerut 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Tariq Khan |
Clinical Research Unit, Meerut |
Research OPD Room BawÄsÄ«r DÄmiya (Bleeding Piles), Cantonment General Hospital, Begum Bridge
Meerut
UTTAR PRADESH |
9012843253
doctormtk@gmail.com |
| Dr Mumtaz Ahmad |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Research OPD Room BawÄsÄ«r DÄmiya (Bleeding Piles) Guzri, Patna City
Patna
BIHAR |
9415366621
ahmadmumtaz1966@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit (CRU), Meerut |
Approved |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon Teewaj |
5gm (semisolid) orally twice daily to be taken with water after meals for 42days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender in the age group of 18-65 years
2. Patients having Rectal bleeding with two or more of the following symptoms of Bleeding Piles
Constipation
Mucus discharge
Rectal fullness or discomfort
Anal Itching
3. Patients of Rectal bleeding diagnosed / confirmed by proctoscopy examination
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 & above 65 years of age
2. Advanced hemorrhoids requiring surgery i.e. 3rd & 4th degree hemorrhoids
3. Patients with anal fissure and fistula in-ano
4. Patients with rectal prolapse, rectal polyp and palpable abdominal mass
5. Known cases of Carcinoma, Inflammatory Bowel Disease (Ulcerative colitis, Crohn’s disease etc.)
6. Known cases of Anaemia, uncontrolled Diabetes mellitus, Chronic hepatic, renal or cardiac ailments
7. History of long-term medication
8. History of drug addiction
9. Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of BawÄsÄ«r DÄmiya (NUMC: F-96) (Bleeding Piles) |
At baseline, day 14th, 28th and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
At baseline, 14th day and at the end of treatment |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
08/05/2023 |
| 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="2"
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 multicentric open trial in patients with BawÄsÄ«r DÄmiya (Bleeding Piles). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Majoon Teewaj 5gm twice daily for 42 days. The patients will be assessed clinically at days 14th, 28th and 42nd day. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 42days. Laboratory parameters for safety assessment will be conducted at baseline, 14th day and on completion of the protocol therapy.
| S. No. | Ingredients | Botanical /Scientific Names | Quantity | | 1. | Teewaj-e-Khatai | Holarrhena antidysenterica L. Wall. | 1 Kg | | 2. | Bekh-e-Anjabar | Polygonum bistorta L. | 240 g | | 3. | Tabasheer | Bambusa arundinaceae R. | 240 g | | 4. | Damm-ul- Akhwain | Dracaena cinnabari Balf. f. | 240 g | | 5. | Gil-e-Armani | Armenian bole | 240 g | | 6. | Kateera | Cochlospermum religiosum L. Alston. | 240 g | | 7. | Gul-e-Nilofar | Nelumbo nucifera Gaertn. | 240 g | | 8. | Qand safaid | Granular sugar | 7.5 Kg | |