| CTRI Number |
CTRI/2024/08/072303 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on the effects of Hijama-bila-Shart and TENS in the management of Usr-e-Tams Ibtedai (Primary Dysmenorrhea) |
|
Scientific Title of Study
|
A Comparative Clinical Study on the effects of Hijama-bila-Shart and TENS in the Management of Usr-e-Tams Ibtedai (Primary Dysmenorrhea) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Huma Ishrat |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj Uttar Pradesh
Allahabad UTTAR PRADESH 211016 India |
| Phone |
08756413866 |
| Fax |
|
| Email |
huma.tnd1234@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Jamal Akhtar |
| Designation |
Professor |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj Uttar Pradesh
Allahabad UTTAR PRADESH 211016 India |
| Phone |
08052142175 |
| Fax |
|
| Email |
drjamalakhtar@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Jamal Akhtar |
| Designation |
Professor |
| Affiliation |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj Uttar Pradesh
Allahabad UTTAR PRADESH 211016 India |
| Phone |
08052142175 |
| Fax |
|
| Email |
drjamalakhtar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital, Himmatganj, Prayagraj, Uttar Pradesh 211016 , India. |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and Hospital Prayagraj |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj Uttar Pradesh 211016 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Huma Ishrat |
State Unani Medical College and Hospital Prayagraj,U.P. |
Department of Ilaj-bit-Tadbeer, Room No. 2 , Ground Floor Allahabad UTTAR PRADESH |
08756413866
huma.tnd1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, State Unani Medical College and Hospital, Prayagraj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama-bila-Shart ( Dry Cupping ) |
Size of cup: Medium, 5cm
No. of cups: 3- 5 cups
Site: below umbilical region (both iliac fossa and suprapubic region)
Duration of intervention: 15-20 Minutes.
Duration of protocol: 3 months.
Intervention will be done on alternate days from 7 th day of menses up to before menstruation for 3 consecutive cycle. Assessment will be done at day 0 before starting the procedure, 1st cycle, 2nd cycle and after the completion of the study i.e., on 3rd cycle. |
| Comparator Agent |
Transcutaneous Electric Nerve Stimulation (TENS) |
Frequency: 50 - 120 Hz
Duration of intervention: 15-20 Minutes.
Site: below umbilical region (both iliac fossa and suprapubic region)
Duration of protocol: 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Having regular menstrual cycle.
Lower abdominal pain, with cramp along with nausea, vomiting and backache.
Unmarried women.
Absence of any pelvic pathology.
Patient with oligomenorrhoea and painful menstruation.
Obtaining a score higher than four on the pain Visual Analogue Scale.
|
|
| ExclusionCriteria |
| Details |
Age below 13year or above 30 year.
Any systemic illness such as Liver, Cardiac, Pulmonary, Diabetes mellitus and Hypertension, Hypothyroidism etc.
History of any skin allergy, epilepsy or convulsions.
Patient taking NSAIDs and on Hormonal therapy.
Any gynecological disorders like DUB, PID, Ovarian cyst, Uterine fibroid, Irregular menses.
History of Recent Surgery.
Umbilical hernia or any Incisional hernia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain intensity
1.VAS ( Visual Analogue Scale)
2.VMSs ( Verbal Multidimensional Scoring System)
|
Day 0, 1st, 2nd, 3rd menstrual cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life
1.MSQ (Menstrual Symptom Questionnaire) |
Day 0, 1st, 2nd, 3rd menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dysmenorrhea is a common gynecological problem in women of reproductive age. In general, it begins with the first ovulation cycle and occurs about two years after menarche and most of the severe episodes occur before 25 years of age. Dysmenorrhea word is derived from Greek language ‘dys’ meaning ‘difficult’, ‘painful or abnormal’, ‘meno’ meaning ‘month’ and ‘rrhoea’ meaning ‘flow’ that means ’Painful menstrual flow. The affected women experience sharp, intermittent spasm of pain usually concentrated in the suprapubic area but pain may also radiate to the back and along the thighs. It affects more than 50% of menstruating women in age group 18- 25 years. It is estimated that 60% of girls of 12-17 year of age group complaint of dysmenorroea and 50% of women experienced some degree of dysmenorrrhoea, while 10% are incapacitated by it. It has been also estimated in some studies upto 75% of young women will experience some dysmenorhhoea in spontaneous menstrual cycle with 15-20% of women experiencing severe pain. In Unani System of Medicine dysmonorhhoea is known as ‘Usr-e-Tams’ but most of the Unani physicians such as Ibn-e-Sina and Abu Bakar Zakaria Razi described the term “dysmenorrhea†under the context of “auja-e-rahem†that is the pain of uterine origin. They had sound knowledge of this condition and mentioned their personal experiences under various topics like ‘Su-e-Mizaj mukhtalif’, ‘ghaleez balghem wa sauda’, ‘reeh’, ‘Ihtebas-e-tams’, ‘warm-e-rahem’. Zakaria Razi in his book ‘Alhavi fit tib’ mentioned that causes of dard-e-rahem are ‘warm-e-rahem’ , ‘ahtebas-e-tams’, ‘seelan-e-khoon’, ‘seelane-e-mani’, ‘dabela’ , ‘insedade fam-e-rahem’ , and ‘ikhtenaqur rahem. In ‘Alqanoon fit tib’ , Ibn e sina said that Usr-e-Tams is caused by different type of su-e-mizaj, amraz-e-rahem sabiqa, Qillat-e-tams, insedade fam-e-rahem, and sartan-e-rahem. Hakeem Azam Khan in his book Kitabul Akseer-e-Azam described lots of cause of dymenorhhoea such as su-e-mizaj or tamaddudi riyah, mugallid-e-riyah, and nafakh-e-rahem etc. Unani Physicians worked on the theory of temperament and succeeded in locating the relationship between diseases, variation of humours and disturbance of the temperament. In Unani system of medicine, treatment is based on the understanding that a particular illness in the patient has developed due to disharmony in her temperament, which has deviated from its equilibrium status. Therefore, the objective of treatment is rectification of the disturbance of temperament. According to Unani physicians, it is the altered temperament (Su-e-Mizaj) that causes obstruction in flow of menstruation fluid that results difficult menstruation. Treatment is therefore, aimed directly at restoring balance to patient’s temperament or humours. The conventional medicines prescribed for treatment of dysmenorrhea are NSAIDs and OCPs (prostaglandin inhibitors) that have notable side effects like nausea, stomach irritation, gastrointestinal ulcers and impaired renal blood flow etc. Therefore, Unani drugs formulations, and Regimenal therapies like hijama (cupping), fasd (venesection), dalk (massage) and physical exercises etc. which have least or no side effect on human body, so that many people generally attracted towards the Unani system of medicine. Hijama-bila-Shart has great potential to treat Usr-e-Tams according to most of the Unani scholars. In spite of that, Unani system of medicine is a need of the hour to evaluate the significant scientific validation and documentation of Hijama-bila-Shart. The scientific validation of Hijama-bila-Shart in the management of Usr-e-Tams will help to approve by the other countries worldwide in the scientific era. Thus, Hijama-bila-Shart will become more widely accepted and effective treatment of Usr-e-Tams by the society globally. TENS (Transcutaneous Electrical Nerve Stimulation), is the application of moderate frequency current in the form of pulsed rectangular currents via surface electrodes on patients skin to reduce pain. It is non invasive conventional intervention to treat pain conditions. Specifically, high frequency TENS, which involves electric puls delivered between 50 and 120 Hz has been found to be more effective in primary dysmenorrhea, it is safe, portable and inexpensive. The present study has been designed to compare and evaluate the effects of Hijama-bila-Shart with TENS in the management of Usr-e-Tams Ibtedai (Primary Dysmenorhhoea). Therefore, the present study is entitled as “A Comparative Clinical Study on the Effects of Hijama-bila-Shart and TENS in the management of Usr-e-Tams (Primary Dysmenorrhoea)â€. |