Effect of Althea officinalis Linnaeus (Tuqme khatmi) in Cervicitis (Iltehabe unqur rehm) - An Open Observational Clinical Study

Introduction: Cervicitis (Iltehabe unqur rehm) is characterized by inflammation of the cervix. Patients may present with complaints of abnormal vaginal discharge, post coital bleeding, dyspareunia, lower backache and lower abdominal pain. In Unani system of medicine Tukhme khatmi has been Discharge selected out from various available drugs in sailan ur raham . Aim: To evaluate the effect of Tukhme khatmi (Althea officinalis Linnaeus) in cervicitis. Materials and Methods: Clinically diagnosed patients (n=30) married women between age group of 18-45 yrs with regular menses were included considering selection criteria. Safuf of tukhme khitmi 5gms with Shahed and marham of tukhme khitmi will be prepared as per standard preparation. Safuf twice daily orally and Humul at bed time for 21 days after menses with weekly follow up. Subjective and objective parameters were assessed. Primary outcome and Secondary outcome were assessed for Improvement in Abnormal Vaginal LBA, LAP, CB, dyspareunia, VSS score, VAS and SF-12 for QOL and for any adverse effect safety profile was done. Results: there was a significant improvement in abnormal vaginal discharge with a mean of 2.37±0.56 BT and 0.37±0 AT with p <0.0001 and other associated sign and symptoms of cervicitis. VSS with a mean of 1.80±0.48 BT and 0.03±0.182 AT shows significant change with p <0.0001 after intervention. QOL was markedly improved. Conclusion: Considering the above result tuqme khitmi is effective in alleviating symptoms of cervicitis. It can serve as an alternative treatment without any side effects and it is also cost effective. Further research is needed in large sample size for longer duration.


INTRODUCTION
Cervicitis is an inflammation of the uterine endocervix's columnar epithelium.Acute or chronic symptoms can occur, with infectious causes causing acute symptoms and non-infectious agents causing chronic symptoms. [1]The disease's clinical range includes anything from asymptomatic cases to patients with mucopurulent cervical discharge and systemic symptoms.Regardless of how they appear on the surface, any of these circumstances could result in life-threatening outcomes such as pelvic inflammatory disease (PID). [2]As a result, it's vital for the doctor to identify the symptoms as soon as feasible, investigate and make a diagnosis, and begin effective treatment as soon as possible. [3]he most common age group is sexually active women aged 15 to 24.Purulent or mucopurulent vaginal discharge, as well as intermenstrual or post-coital hemorrhage, are common symptoms. [4,5]Dyspareunia has been reported as well.In addition, the related symptoms, LBA and abdominal discomfort, post coital bleeding should be evaluation.In classical Unani literature, Iltihabe -unuq-al-Rahim is of three type's waram harr, barid and sulb.The waram is harr and it may be due to inflammation or sue mizaj.The other causes are retention of matter (madda) as in

Effect of Althea officinalis Linnaeus (Tuqme khatmi) in Cervicitis (Iltehabe unqur rehm) -An Open Observational Clinical Study
The duration of the study was one and a half years.The method of collection of data was History Taking and Clinical examination.

Inclusion criteria
Women between 18-45 years of age, Cervicitis is diagnosis through P/S examination (Hypertrophy, congestion, redness and Nabothian cyst on cervix), Vaginal discharge, low backache, lower abdominal pain, Inflammatory changes in Pap smear.

Study design
An observational clinical study.

Study duration
One and half year from December 2020-February 2022.
Sample size 30 patients.

Informed consent
All the participants gave written informed consent before the study starts.

Drug Identification
Was done at FRLHT Bengaluru with an a/c no.03711450000072.Chromatography of stud Drug Althea officinalis Linnaeus (Tuqme khatmi) done by HPTLC method using CAMAG apparatus: Althea officinalis_20220705_145730 Std.Prep.: 10mg sample soaked in methanol overnight.Mobile phase: toluene: etyhl acetate (48.5:1:5) wavelength: 220nm.The sharp peak indicates presence of respective standards are present, this indicates the purity level of these three standards are good.

Selection criteria
Women between 18-45 years of age.Having symptoms of Abnormal Vaginal discharge, low backache, lower abdominal pain post coital bleeding, dyspareunia, inflammatory changes in Pap smear were included.Patients with PID, Malignancy, Benign lesion, Systemic diseases like HTN, DM, STDs, and contraceptive Pregnancy and lactation were excluded.

Study procedure
The Inclusion criteria fulfilled patients were included in study.
Participants were asked to provide details on their demographic data.Menstruation cycle with the medical history.In each patient, history is evaluated and a complete physical examination was performed including gynaecological examination.Personal details, history clinical examination, investigations, per vaginal examinations were recorded in case record form structured for the study.

Method of preparation
The best quality of tuqme khitmi was provided by the pharmacy of NIUM and was further authenticated by FRLHT Bengaluru.With an a/c no.03711450000072.The drug is finely powdered as per standard preparation.About 40gms of safuf was packed for 1 week and 40ml of shahad for a week was dispensed for 3 weeks.Sufuf of Tuqm-e-Khitmi [9] 5gms with Shahed 5ml orally and marham of tuqme khitmi was given for humul at bed time for 21 days after completion of menstrual periods.

Initial assessment and laboratory screening
Baseline laboratory investigations like haemoglobin, percentage, total leucocytic count, differential leucocytic count, erythrocyte sedimentation rate, random blood sugar urine routine was done to exclude the general diseases.Ultrasonography of pelvis was done to exclude pelvic pathology in each case.Pap smear was done to exclude genital malignancy and Inflammatory smears or bacterial vaginosis were included.Safety profile Blood Urea, Serum Creatinine, AST, ALT and Alkaline Phosphatase, was done before and after the intervention for the safety of test drug.Assessment of Patients were followed during trial, start on 5 th day of menses and continue upto 21 days the trial follow-up by Weekly.During this period, Abnormal Vaginal Discharge was assessed, using scales Vaginal Symptom Scale (VSS) [10] score and LBA, lower abdominal pain was assessed using Vaginal Analogue Scale (VAS). [11]Score separately.SF12 Score for health-related quality of life in cervicitis patients. [12]atient were also enquired for any adverse effect of research drugs during the study period.

Objective parameters
Vaginal symptom score scale (VSS) for vaginal discharge, and visual analogue scale (VAS) for low back ache and low abdominal pain.SF12 Score for health-related quality of life in cervicitis patients.

Outcome measures
It is assessed by change in subjective and objective parameters.

Statistical analysis
Descriptive and inferential statistical analysis has been carried out in the present study.Results on continuous measurements are presented on Mean ± SD (Min-Max) and results on categorical measurements are presented in Number (%).5][16][17]

RESULTS AND DISCUSSION
The present study entitled "Effect of Tuqme Khitmi in cervicitis-An open observational clinical study" was effective in treating the symptoms of cervicitis.In the present study it was demonstrated that Mean±SD before and after treatment were 1.93±0.52 and 0.13±0.34with p <0.0001, considered as highly significant.And achieved no discharge in 86.7% and mild discharge in 31.3% of patients after treatment.70% had no Low back ache with a mean of was1.6±0.81 and 0.3±0.46before and after treatment respectively with p<0.0001, considered as highly significant.No adverse effect of unani research drug was reported during the study.

Baseline data has been represented in (Table 1) Age
A similar study conducted by Jeanne M. et al. observed 40% patients were from > 30 years of age.Ameri B et al. reported with a mean age 32.1±8.5 of cervicitis. [18]Warm al-raham also classified according to age by Ansari S. et al. mentioned that most commonly occurs in 31-40 years of age. [23]Hashmi S. et al. reported majority of the women were between the age group of 20-40. [19]

Socioeconomic status
Similar study conducted by S. Ansari et al. and MS Kaveri.et al. showed that majority of patients 19 (63.3%) and 40(33.3%)respectively were from lower middle and middle class. [20,21]while Hashmi S. et al. showed that the majority of patients were from Upper lower 13(43.33). [19]

Mizaj
In this study maximum patients, 24(80.0%)possessed balghami mizaj followed by 6(20.0%)damvi mizaj, none of the patients had safrāvi and saudavi mizaj.It is in accordance with the theories proposed by eminent unani physician, who have quoted that this disease is more common in individual with dominance of khilt-i-balgham.Similar finding was reported by Ansari et al. 25 (83.3%)patients were from balghami mizāj. [20]

Age of menarche
In this study, majority 17(56.7%) of the patients were attained menarche of 13-15 years of age followed by 13(30.0%) at 11-12 years.

Low backache
The findings of present study are comparable with S. Ansari et al. reported 3(10%) patients had mild LBA, 26(86.7%)moderate and 1(3.3%) had severe and 90% patients were improved with a mean of 1.6±0.81 and 0.3±0.46before and after intervention respectively, with p<0.0001. [20]nees S. et al. reported 100% of patients complaining of LBA before treatment in which 66.7% got relieved after treatment. [22]Which is corelating with present study.

QOL by SF-12 score
The mean± SD before intervention was 382.73± 52.33 and after it was 910.17±56.30with p<0.0001 which is extremely significant and improvement of 43.3% in >400 score.(Table 9).

Strength of the study
This study was an open single centered observational study.Where treatment was given both orally and locally as hamūl of research drug which is directly affected the vaginal discharge, congestion and hypertrophied of cervix.There was good compliance to management.

Limitations of the study
The main limitation of this study was with small sample size, short duration of intervention, short follow up.Laboratory test will not verify the efficacy of result was not performed.

Future recommendation
Use of research unani drug orally and as hamūl for longer duration, on large sample size of patients with long follow up for better therapeutic outcome.RCT's with oral and hamūl of same research drug with standard treatment i.e., cauterization either electro-cautery or cryocautery is recommended.

CONCLUSION
The present study was carried out to prove the efficacy of tukhme khitmi in warme unqur rahim (Cervicitis) in the form of hamūl and orally.The improvement in vaginal discharge, congestion of cervix, hypertrophy of cervix and other associated symptoms Viz, LAP, LBA, dyspareunia, may be due to qabis, habis, mujaffif, dafe taffun, muhallile waram properties of the unani drug.Pharmacological studies shows that research drug exhibit anti-microbial, anti-inflammatory, analgesic, antiseptic, antioxidant and anti-ulcer ameliorated the sign and symptoms of cervicitis.However, no adverse effect of the research unani drug was reported during the trial.It can be inferred that the research drugs have affected on the clinical parameters through its effect on cervicitis.On the basis of above observation, it can be concluded that this drug is very effective in relieving the symptoms and sign of cervicitis.The drug is cost effective easily available and well tolerated by the patients without having any side effects.

Table 10 : Outcome in cervicitis patients studied.
It is a pleasure to thank Dr. KP Suresh biostatistician and scientist, National Institute of Veterinary Epidemiology and Disease informatics (NIVEDI) for performing the statistical analysis.