Effect Of Soubhagya Shunthi Leha In Sutika Makkala(Puerperal Pain)

Phase 3

Not yet recruiting

• Conditions: Complication of the puerperium, unspecified. Ayurveda Condition: SUTIKAROGAH,

• Registration Number: CTRI/2023/10/058253
• Lead Sponsor: Dr Reeta C Vajramatti

Brief Summary

- Sutika Makkala is one among 74 Sutika vyadi’s. Sutika Makkala occurs due to aggravation of vata Dosha and incomplete evacuation of Shonita from the Garbhashaya after Prasava that cause Shoola in Basti, Shiras and Udara.

- Sutika Makkala can be co- related to "Puerperal pain" characterized infrequent spasmodic pain in lower abdomen due to hypertonic contraction of the uterus to expel remainants of blood clots or any bits.

- Soubhagya shunti leha mentioned Bhaishajya Ratnavali is selected for this study to evaluate its effect in the management of Sutika Makkala(Puerperal pain).

- This is a single arm open label clinical trial. Total 30 patient of Sutika Makkala who fulfill the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Sutika Makkala are selected.

- Total Study duration will be 30 days and contain 3 visits (0th day, 15th day, 30th day), which includes administration of trial drug for 15 days and post medication follow up 30th days.

- After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-27
• Study Start: 2023-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• 1.Married patients both primi Para and multi Para are taken.
• 2.Patients with full term normal vaginal delivery.
• 3.Patients willing to sign the consent form.

Exclusion Criteria

• 1.Patients with Complication of IUD, Sepsis, PIH, and third stage of labour.
• 2.Patients with Systematic Disorders like Diabetes Mellitus, Hypertension, and Tuberculosis.
• 3.Instrumental Delivery, LSCS patients.
• 4.K|C|O –STDs, HIV, HBsAG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of trial drug on the symptoms Udara Shoola, Adhmana, Shirashoola, Bastishools of Sutika Makkala(Puerperal pain).	15th day , 30th day

Secondary Outcome Measures

Name	Time	Method
Safety of trial drug and Adverse Drug Reaction	Aggravation of Symptoms of Sutika Makkala(Puerperal pain)

Trial Locations

Locations (1)

Padma Ayurvedic Hospital And Research Centre; 🇮🇳 Bagalkot, KARNATAKA, India

Padma Ayurvedic Hospital And Research Centre

🇮🇳Bagalkot, KARNATAKA, India

Dr Reeta C Vajramatti

Principal investigator

9449532200

vajramattireeta@gmail.com