| CTRI Number |
CTRI/2020/02/023428 [Registered on: 19/02/2020] Trial Registered Prospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Abnormal Excessive Vaginal Discharge by Unani medicine Sailani |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Sailani in SayalÄn al-Rahim (Abnormal Excessive Vaginal Discharge) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SR/EAVD/S/CLNVAL/CCRUM /18-19, Version 1 |
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 |
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 |
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 |
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), Mumbai 2. Regional Research Institute of Unani Medicine (RRIUM), Aligarh 3. Clinical Research Unit (CRU), Bhopal 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Afshan Qaiser |
Clinical Research Unit (CRU) |
Research OPD (Female) room SayalÄn al-Rahim
Department of Pharmacology, Gandhi Medical College
Bhopal
MADHYA PRADESH |
9074743166
afshan.qaiser@gmail.com |
| Dr Nikhat Shaikh |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD (Female) room SayalÄn al-Rahim
Behind Eye Bank, Sir J. J. Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
9820399433
drnikhat.unani@gmail.com |
| Dr Shagufta Rehman |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD (Female) room SayalÄn al-Rahim
Post Box 70, Firdous Nagar Near AMU Riding Club
Aligarh
UTTAR PRADESH |
9456667107
drrehmanshagufta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Bhopal |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Aligarh |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sailani |
2 tablets orally twice daily to be taken with lukewarm water after meals for two weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Sexually active women of age group 18 – 45 years.
2.All women complaining of vaginal discharge.
3.Associated symptoms:
I. Vulval Itching
II. Low Backache
III. Generalised weakness
IV. Burning Micturition
V. Abnormal vaginal odour
4.Patients willing to take part in study.
|
|
| ExclusionCriteria |
| Details |
1. Patient more than 45 years of age.
2. Menopausal, Pregnant and Lactating women.
3. Known cases of any systemic illness like hypertension, diabetes mellitus.
4. Patients with H/O fibroid, polyp, ovarian tumour or cyst, uterine-prolaps and malignancy.
5. Patients using OCPs or intrauterine devices.
6. Known cases of HIV, Syphilis, Gonorrhoea.
7. Patients having acute/acute-on chronic/Chronic PID as per CDC Criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of SayalÄn al-Rahim (Abnormal Excessive Vaginal Discharge) |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
28/02/2020 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric open trial in patients with SayalÄn al-Rahim (Abnormal Excessive Vaginal Discharge). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Sailani two tablets twice daily with water for four weeks. The patients will be assessed at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be four weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. Composition of Sailani | S.No. | Ingredients | Scientific Name | Quantity | |
| Kushta Baize Murgh | (Hen’s Egg Shell) Calcinate | 200 g | |
| Kushta Sadaf | (Pinctada margaritifera) pearl-shell calcinate | 280 g | |
| Maghz-e-Tukhm-e-Tamar Hindi Biryan | Tamarindus indica | 1.5 kg | |
| Kamarkas (Samag dhak) | Butea monosperma | 6.50 kg | |
| Taj Qalmi | Cinnamomum cassia Blume | 6.50 kg | |
| Dana Ilaichi kalan | Amomum subulatum Roxb | 3.25 kg | |
| Tabasheer Mehlool | Bambusa arundinacea Willd | 3.25 kg | |
| Busud ahmar | Corallium rubrum | 3.25 kg | | | Satawar | Asparagus racemosus Willd. | 3.25 kg | | | Mocharas | Salmalia malabarica | 3.25 kg | |
| Phali babool | Acacia arabica | 3.25 kg | |
| Kishneez khushk | Coriandrum sativum | 3.25 kg | |
| Khurfa siyah | Portulaca oleracea | 3.25 kg | |
| Mazu sabz | Quercus infectoria | 3.25 kg | |
| Paraffin | --- | 1 kg | |
| Sang-e-jarahat | Hydrated Magnesium Silicate | 1.50 kg | |
| Qand safaid | Sugar (Saccharum officinarum Linn.) | 24 kg |
|