| CTRI Number |
CTRI/2025/08/092362 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Haemorrhoid (Bawaseer) with Unani Medicine Habb-e-Anjeer |
|
Scientific Title of Study
|
Clinical Validation of Unani pharmacopoeial formulation Habb-e-Anjeer in Bawaseer (Haemorrhoids). |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| B/H/HA/CLNVAL/CCRUM/23-24, version No-01, 14.07.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| 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
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
India
South West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.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
India
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural Support: Regional Research Institute of Unani Medicine, 1, West Meda Church Street, Royapuram, Chennai – 600013, TAMIL NADU . |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
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 Sayyed Adnan Mohammad |
Regional Research Institute of Unani Medicine |
Research opd room Bawaseer (Haemorrhoid), 1, West Meda Church Street, Royapuram, Chennai – 600013
Chennai
TAMIL NADU |
9767488918
sayyed224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e- Anjeer |
2 Pills (1 gm each) Twice a day With water after meal for 6 weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Internal Haemorrhoids presenting with any of the following symptoms:
1. Mucoid Anal and Perianal Discharge
2. Pruritus Ani (Hikka al-Maq‘ad)
3. Rectal and Anal Pain (Waja-al-Maq‘ad)
4. Rectal Bleeding
|
|
| ExclusionCriteria |
| Details |
1. Third & Fourth Degree Internal Haemorrhoids,
2. Severe Anaemia (Hb less than 8 g/dL)
3. Known cases of fistula and fissure in anal canal
4. Patient with rectal prolapse, polyp and abdominal mass.
5. Known cases of IBD & Bowel carcinoma.
6. Immuno-compromised clinical conditions such as diabetes mellitus type 2, HIV/AIDS, cancer, etc.
7. Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.)
8. Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the study drug in the treatment of Bawaseer (Haemorrhoids) will be assessed on the basis of Haemorrhoidal Disease Symptom Score i.e., Pain, Itching, Bleeding, soiling, and prolapse as proposed by Nyström et al (2010). |
At baseline and every two weeks. (i.e., 0, 2nd, 4th, and 6th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline, first follow up and the end of treatment. (i.e., o, 2nd and 6th week) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 2 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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 Applicable |
| 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
|
This study is designed as an open-label, single-centre prospective clinical validation study in participants with Bawaseer (Haemorrhoids). After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks (i.e.,0, 2nd, 4th and 6th weeks). This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 6 weeks. Laboratory parameters for safety assessment will be conducted at baseline, first follow-up and on completion of the protocol therapy (i.e., 0, 2nd, and 6th weeks). Composition of Habb-e-Anjeer (NFUM, Part- II, P.N. 8)
| S. No. | Ingredients | Botanical Name | Quantity | | 1 | Badiyan | Foeniculum vulgare Mill | 40 g | | 2 | Post-e-Halela Zard | Terminalia chebula Retz. | 40 g | | 3 | Post-e-Balela | Terminalia bellirica (Gaertn.) Roxb. | 40 g | | 4 | Amla | Emblica officinalis Gaertn. | 40 g | | 5 | Muqil | Commiphora wightii (Arn.) | 40 g | | 6 | Rasot | Berberis aristata DC. | 40 g | | 7 | Tukhm-e-Gandana | Asphodelus tenuifolius Cav. | 10 g | | 8 | Anjeer | Ficus carica L. | 5 in number | | 9 | Maweez | Vitis vinefera L. | 70 g |
|