Clinical assessment for safety and helpful two Ayurvedic products, Shelora and Shelora Plus in women who have menstrual problems or are going through the phase before menopause (when periods start becoming irregular and symptoms like mood changes or hot flashes may occur)

A prospective, randomized, double-blind, parallel-group, placebo-controlled, proof-of-concept clinical study to evaluate the safety and efficacy of Shelora (DVB-01/26) and Shelora Plus (DVB-02/26) in women with menstrual disorders and perimenopausal symptoms. - Nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109440

Enrollment

Registered

2026-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N912- Amenorrhea, unspecified Health Condition 2: N950- Postmenopausal bleeding

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: For All Participants: 1. Females aged 18 to 45 years 2. Using non-hormonal contraception 3. Able and willing to provide written informed consent 4. Willing to comply with the study protocol and maintain a daily symptom diary 5. Sexually active and clinically healthy (based on medical history, physical examination, vital signs, and laboratory investigations) Group A: Menstrual Disorder (18 to 35 years) 1. Females aged 18 to 35 years with BMI 18.5 to 29.9 kilograms per square meter 2. Diagnosed with at least one of the following: a. Dysmenorrhea b. Menorrhagia c. Irregular menstrual cycles (cycle length variability greater than 7 days across 3 or more consecutive cycles) 3. FSH and LH within normal reproductive range 4. VAS pain score greater than or equal to 4 (0 to 10 centimeter scale) Group B: Perimenopausal (36 to 45 years) 1. Females aged 36 to 45 years with BMI 22 to 29 kilograms per square meter 2. Early perimenopausal stage as per STRAW plus 10 criteria: a. Cycle variability greater than 7 days b. No skipped cycles 3. Menopause Rating Scale (MRS) score greater than or equal to 18 4. FSH greater than 20 international units per liter and LH within expected perimenopausal range

Exclusion criteria

Exclusion criteria: For All Groups 1. Known hypersensitivity to any component of Shelora or Shelora Plus 2. Pregnant or lactating women or those planning pregnancy during the study 3. Active systemic or pelvic infection at screening 4. Recent major surgery 5. Participation in another clinical trial in the last 3 months 6. Use of hormonal herbal steroid therapy or recreational drugs within the last 6 months 7. Diagnosed with PCOS endometriosis uterine abnormalities fibroids greater than 3 cm structural uterine abnormalities or pelvic inflammatory disease 8. History of thromboembolic events cardiovascular disease or malignancy within past 5 years Hypertension greater than or equal to 160 by 100 mmHg 9. Abnormal FSH or LH levels suggestive of endocrine or ovarian disorders or abnormally high or low FSH or LH inconsistent with reproductive or perimenopausal stage 10. Clinically significant hepatic renal metabolic or endocrine disorders

Design outcomes

Primary

Measure	Time frame
For 18- 35 yrs Change in menstrual pain intensity measured by Visual Analog Scale (VAS, 0 10) from baseline to 8 weeks Change in bleeding pattern, assessed by: Bleeding volume Bleeding duration Change in cycle regularity, measured as number of days between two consecutive menstrual cycles Change in hormonal and metabolic parameters: FSH LH SHBG Total testosterone HOMA-IR For Perimenopausal Women (36 45 years) Change in Menopause Rating Scale (MRS) total score from baseline to 8 weeks Change in Hot Flush Weekly Weighted Score (HFWWS) Change in hormonal levels: FSH LH (towards expected perimenopausal range)Timepoint: Day 0 Baseline, Day 28, Day 56 and Day 67	—

Measure

Time frame

For 18- 35 yrs Change in menstrual pain intensity measured by Visual Analog Scale (VAS, 0 10) from baseline to 8 weeks Change in bleeding pattern, assessed by: Bleeding volume Bleeding duration Change in cycle regularity, measured as number of days between two consecutive menstrual cycles Change in hormonal and metabolic parameters: FSH LH SHBG Total testosterone HOMA-IR For Perimenopausal Women (36 45 years) Change in Menopause Rating Scale (MRS) total score from baseline to 8 weeks Change in Hot Flush Weekly Weighted Score (HFWWS) Change in hormonal levels: FSH LH (towards expected perimenopausal range)Timepoint: Day 0 Baseline, Day 28, Day 56 and Day 67

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Secondary

Measure	Time frame
Group A: Menstrual Disorders (18 35 years) Change in hirsutism score using Modified Ferriman Gallwey (mFG) scale from baseline to 8 weeks Change in Menstrual Symptom Severity Questionnaire (MS-SSQ) score from baseline to 8 weeks Change in anthropometric parameters: Body weight Waist circumference Hip circumference Change in bloating and breast tenderness (VAS) from baseline to 8 weeks Group B: Perimenopausal Women (36 45 years) Change in Integrative Medicine Outcome Scale (IMOS) from baseline to 8 weeks Change in Integrative Medicine Patient Satisfaction Scale (IMPSS) from baseline to 8 weeks Change in symptoms assessed by VAS: Bloating Breast tenderness Joint stiffness Vaginal dryness Memory complaints Change in self-assessed skin and hair quality scores from baseline to 8 weeksTimepoint: Baseline day-1, Day 28 ( 3 days), and End of Treatment (Day 56 60); safety follow-up at Day 67 ( 5 days)	—

Measure

Time frame

Group A: Menstrual Disorders (18 35 years) Change in hirsutism score using Modified Ferriman Gallwey (mFG) scale from baseline to 8 weeks Change in Menstrual Symptom Severity Questionnaire (MS-SSQ) score from baseline to 8 weeks Change in anthropometric parameters: Body weight Waist circumference Hip circumference Change in bloating and breast tenderness (VAS) from baseline to 8 weeks Group B: Perimenopausal Women (36 45 years) Change in Integrative Medicine Outcome Scale (IMOS) from baseline to 8 weeks Change in Integrative Medicine Patient Satisfaction Scale (IMPSS) from baseline to 8 weeks Change in symptoms assessed by VAS: Bloating Breast tenderness Joint stiffness Vaginal dryness Memory complaints Change in self-assessed skin and hair quality scores from baseline to 8 weeksTimepoint: Baseline day-1, Day 28 ( 3 days), and End of Treatment (Day 56 60); safety follow-up at Day 67 ( 5 days)

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Countries

India

Contacts

Public ContactMr Bharat Sharma

New Life Womens Hospital

drjatan83@gmail.com9662420889

Outcome results