Efficacy of Asgand and Khare khasak in polycystic ovarian syndrome- A Pilot Study

Objective: Efficacy of  Asgand and Kharkhask in   polycystic ovarian syndrome.

Source of Data:

Patients attending NIUM Hospital, Bangalore

Method of Collection of data:

• Clinical History and Examination.
• Laboratory Investigations.

Inclusion Criteria:

1. Patients aged 18-35
2. Oligomenorrhoea or amenorrhoea
3. Clinical evidence of hyperandrogenism ( Hirsuitism / Acne)
4. USG findings of PCO

Exclusion Criteria:

1. Patients  with Hormonal treatment
2. Patients with H/o DM, Hypertension
3. Pregnant and lactating women. 16

Sample size: 30 patients

Study design:  A Pilot study

Subjective Parameters:

1.      Oligomenorrhoea / Amenorrhoea

2.      Hirsutism

3.      Acne

Objective parameter:

1.      USG - Pelvis for ovarian volume

2.      Ferriman Gallwey score for hirsutism

3.      Acanthosis Nigricans Scale

Intervention:

Intervention: Asgand (Withania somnifera Dunal) and Khare khasak (Tribulus terrestris Linn)

Method of Preparation: Asgand and  Khare khasak will be taken in a ratio of 1:2 and safoof  will beprepared according to the standard method of preparation.

Route of Administration and Dosage:  7 gms twice daily from 5th day of cycle for 21 days.

Duration of Protocol Therapy: 3 cycles

Duration of Study: Two years

Follow up:

During treatment: After menstruation for 3 cycles.

After treatment: Once in the subsequent cycle.

Procedure of study:Diagnosed cases of PCOS (n=30) in age group of 18-45 years will be included in the study after obtaining the written informed consent. 7 gm of  safoofof Asgand and Khare khasak with 5gms honey will be given twice daily from 5th day of cycle for 21 days     Follow up of the patients will be done after menstruation for 3 consecutive cycles during treatment and once in subsequent cycle after completion of treatment. Menstrual regulation, changes in FG score, Acanthosis  Nigricans  scale score and ovarian volume on ultrasound will be assessed during the study.

Withdrawal Criteria:

1.      Failure to follow the protocol.

2.      The cases in which drug adverse reactions will be noticed.

Informed Consent:

Patients fulfilling the inclusion criteria mentioned above will be given the information sheet having details regarding the nature of study, and the drugs to be used. Patients will be given enough time to go through the study details mentioned in the information sheet. They will be given the opportunity to ask any question, and if they agree to participate in the study, they will be asked to sign the informed consent form.

Assessment of Efficacy:

1.      Primary outcome measures - Menstrual regularity

2.      Secondary outcome measures – USG Changes for ovarian volume.

Assessment of Safety:

1.      Clinical symptoms.

2.      Laboratory investigations.

Adverse Effects Documentation:

Any adverse of drugs will be documented.

Statistical Analysis:

The appropriate tests will be applied to analyse the data.

Investigations:

Pre test: RBS, Thyroid profile, Serum Prolactin

Pre-Test and Post Test: USG Pelvis for ovarian volume, Lipid profile, LFT, RFT.